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I am presently representing a company in their search for a Quality Assurance Leader to bolster their ambitious business expansion endeavors. The selected candidate will be entrusted with spearheading a team of QA professionals to bolster the company's achievements and successes.
1. Team Leadership:
2. Driving change and transformation:
3. Collaboration and Stakeholder Engagement:
4. Operational Success
To apply, submit your most updated resume showcasing relevant qualifications and experience.
We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
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JOB DUTIES:
JOB REQUIREMENTS:
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About the Role
Morningstar requires a detail driven and passionate Compliance Director, Asia, to lead a small team and be responsible for structuring, maintaining and executing an effective compliance program for the business in Asia. This role will have a primary focus on supporting the business team with implementing a robust compliance program during a period of growth as the business expands its activities. The role is responsible for managing compliance staff in Asia (ex Japan). We are a small team in Asia and are looking for an individual who is able to think strategically and effectively manage the team and workload well, but yet be “hands on” and be willing to do a variety of work, interacting with personnel at all levels from across Asia offices. There may be occasional travel to regional offices in Asia. This position reports to the Global Chief Compliance Officer – Investment, Research and Data and is based in Singapore.
Morningstar is an Equal Opportunity Employer.
Job Responsibilities
Qualifications & experience required:
A98_MstarResSingapor Morningstar Research Pte Ltd. (Singapore) Legal Entity
Morningstar’s hybrid work environment gives you the opportunity to work remotely and collaborate in-person each week. We’ve found that we’re at our best when we’re purposely together on a regular basis, at least three days each week. A range of other benefits are also available to enhance flexibility as needs change. No matter where you are, you’ll have tools and resources to engage meaningfully with your global colleagues.
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Job Description
As a part of our Global Anti Bribery & Corruption (ABAC) Program (“the Team”), Associate Director, Compliance Data Risk Analytics & Monitoring will have responsibility for the management of the Company’s global compliance risk data monitoring program for certain ex-US regions.
In addition, the Associate Director work with the Team to conduct above-region analytics and monitoring focused on transfer of value compliance risk and other compliance projects. The responsibilities will involve cross-functional interface with region and market functions, including Human Health International, International Commercial Operations, and International Legal & Compliance.
Reporting directly to the Executive Director, Global Anti Bribery & Corruption Program, this position is based out of our Headquarter site in Rahway (NJ) with a hybrid setup (combination of an in-office & remote). This position cannot be 100% remote.
Current Position Responsibilities:
Required Experience and Skills:
Preferred Experience and Skills:
Education:
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$122,800.00 - $193,300.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
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POSITION SUMMARY:
Under the direction of the compliance function reporting directly to the Deputy Compliance Officer (“DCO”) this position owns the anti-corruption compliance program for Illumina’s markets in AMEA and Greater China (“AMEA/China Markets”). The DCO ensures that the AMEA/China Markets anti-corruption compliance program is aligned with the 7 Effective Elements of a compliance program as well as the companywide Corporate Compliance Program. This position is responsible for the development, improvement, and day to day activities/management of AMEA/China Markets anti-corruption compliance program and system. With direction from the CCO and DCO this position is also responsible for implementing anti-corruption compliance standards and procedures and ensuring that these standards are communicated and institutionalized throughout the AMEA/China Markets. This position serves as the local subject matter expert on Anticorruption topics or functions. This position requires the ability to be a business partner. This position will collaborate with the compliance functions in the Americas and Europe to ensure regional alignment with the Corporate Compliance Program. This position will also need to team with the Investigations function responsible for anti-corruption investigations when necessary.
PRINCIPAL RESPONSIBILITIES:
EDUCATION / EXPERIENCE REQUIREMENTS:
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
TRAVEL REQUIRED: Up to 25%
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Job Description
General Summary:
The Senior Director, Quality GLP, Biomarkers and Research has overall accountability for strategic leadership and oversight of the end-to-end quality assurance strategy for proactive, risk-informed, and sustainable quality oversight and compliance with regulatory expectations across Vertex processes for clinical evidence generation and product vigilance
Key Duties and Responsibilities:
• Serves as a strategic partner to functional leaders across product modalities responsible for Research (including both non-regulated and GLP work), Biomarker Development, and Diagnostics in assuring appropriate quality/compliance oversight of processes and systems supporting effective delivery of these programs and the rigor and integrity of associated data.
• Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors. Assures operational quality activities are informed by risk and assure the integrity of data submitted to regulatory authorities and in external forums.
• Responsible for assuring that key research & pre-clinical studies (internal and external) are performed in accordance with good scientific practices, good laboratory practices, Vertex policies and procedures and relevant local, regional, and international requirements.
• Leads an operational quality team responsible for identifying and anticipating potential compliance issues that may impact the ability to meet business goals, developing and implementing methods of improvement and resolution in a pragmatic and effective manner
• Oversees effective, timely, and appropriate identification, remediation, and escalation of quality issues in key Research, GLP, Biomarker, IVD and vendor governance-related activities across Vertex.
• Provides periodic updates on the overall health of Research, GLP, Biomarker, and IVD development-related processes and systems to functional leaders across Research, Biomarker Development, and Diagnostics.
• Oversees and assures timely and effective communication of summary trending and other insights on the quality of delivery in research, preclinical, biomarker, IVD work, and vendor performance to relevant business and quality leaders and in relevant forums.
• Oversees Inspection Readiness activities in collaboration with business and Quality Assurance partners related to research, GLP, biomarkers, IVD development activities.
• Chairs relevant operational governance meetings (e.g. QLT)
• Serves as the R&D Quality lead and oversees and guides staff participating in strategic cross-functional initiatives (e.g. Research Ethics, TRPM to improve quality, data integrity, and compliance to regulatory requirements and standards, ensuring a aligned Quality point-of-view is represented.
• Maintains an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Research, GLP, Biomarker, and IVD activities.
• Drives and oversees implementation of new and evolving regulatory requirements related to areas of responsibility.
• Leads and/or participates in industry forums and external initiatives related to areas of responsibility to influence policy development related to oversight of these activities, as aligned with functional leadership and Vertex interests.
• Provides strategic direction, oversight, coaching and mentoring to direct reports.
Education and Experience:
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid #LI-AR1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Job Description
***PLEASE SEND YOUR CV IN ENGLISH***
General position summary:
Associate Director, Regional QA Lead (LATAM & Central America) is a leader within International Quality organization who holds responsibility in ensuring quality compliance in LATAM and Central American Vertex Affiliates. This position holder has an oversight of the distribution network, including distribution partners, and will lead quality oversight initiatives associated with LATAM and Central American region. Associate Director, Regional QA Lead will also ensuring ongoing maintenance of the licenses, leading regulatory inspections, and supporting International Quality in wider regional or global projects.
This Position Reports to: Director, Market Quality
This is a hybrid role based in Sao Paulo, Brazil.
Key Responsibilities:
LATAM & Central American Regional activities:
Key technical knowledge and skills:
Minimum qualifications:
Master’s degree and relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and significant years of relevant work experience.
Qualifications:
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Associate Director of Quality Systems ensures that the GMP systems and controls in place at the site meet Global Quality Standards and applicable regulatory requirements. S/he liaises with Global Quality leadership and is a conduit for driving harmonization and alignment within the biologics network. Additionally responsible for ensuring that significant quality concerns are documented within the Quality Management System (QMS) and for maintaining systems that prompt the appropriate mitigation/remediation actions.
This position typically has oversight of direct reports and will assign resources and priorities, ensure adequate training, coaches and develops staff, evaluates performance, and supports overflow of tasks across Quality as needed. The Director of Quality Systems is a member of the Senior Quality organization and participates in decision making for escalations and communication of decisions at the site.
Key Responsibilities:
Key Qualifications:
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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Make banking a Fifth Third better®
We connect great people to great opportunities. Are you ready to take the next step? Discover a career in banking at Fifth Third Bank.
GENERAL FUNCTION:
Responsible for the continued development and implementation of the Bancorp's compliance programs and management of the related Compliance Managers and teams, including ensuring compliance with Federal laws and regulations and industry standards. Responsible for providing strategic leadership / direction / oversight regarding the Bancorp's compliance risk management programs, including policies, testing, reporting, and control framework. The incumbent is responsible for analyzing current and emerging regulatory trends and proposing and implementing recommendations or system solutions to mitigate identified risk. This position is also responsible for team member development and employee engagement.
Responsible and accountable for risk by openly exchanging ideas and opinions, elevating concerns, and personally following policies and procedures as defined. Accountable for always doing the right thing for customers and colleagues, and ensures that actions and behaviors drive a positive customer experience. While operating within the Bank's risk appetite, achieves results by consistently identifying, assessing, managing, monitoring, and reporting risks of all types.
ESSENTIAL DUTIES & RESPONSIBILITIES:
SUPERVISORY RESPONSIBILITIES: Manage staffing of the Compliance teams to ensure optimal performance in meeting the Risk Management Division's goals and objectives by providing employees timely, candid and constructive performance feedback; developing employees to their fullest potential and providing challenging opportunities that enhance employee career growth; developing the appropriate talent pool to ensure adequate bench strength and succession planning; recognizing and rewarding employees for accomplishments.
MINIMUM KNOWLEDGE, SKILLS & ABILITIES REQUIRED:
WORKING CONDITIONS:
Fifth Third Bank, National Association is proud to have an engaged and inclusive culture and to promote and ensure equal employment opportunity in all employment decisions regardless of race, color, gender, national origin, religion, age, disability, sexual orientation, gender identity, military status, veteran status or any other legally protected status.
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The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is committed to enhancing Australia's biotech landscape through a long-term partnership, focusing on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility is set to be a key player in Australia's response to future health threats. This collaboration emphasizes not only cutting-edge medical technology but also job creation and local talent development. We invite visionary professionals to join us on this transformative journey and make a tangible impact on global health security.
Moderna is seeking an Associate Director for Quality Control at our new manufacturing site in Melbourne, Australia. This role involves overseeing commercial testing functions in the Quality Control department, supporting raw materials and drug substances testing, including microbiological and environmental monitoring tests. The role includes managing laboratory personnel and acting as an interdepartmental liaison, contributing significantly to our quality control and assurance operations.
Here's What You’ll Do:
Within 3 Months, You Will…
Oversee the day-to-day operations of the Quality Control commercial program testing functions, including stability testing.
Ensure timely delivery of test results and provide efficient support for deviations.
Start implementing Lean methodologies to enhance efficiency in the QC processes.
Within 6 Months, You Will…
Manage laboratory personnel, focusing on performance management, mentoring, and career development.
Assist in the development of Standard Operating Procedures and laboratory data systems to ensure cGMP compliance.
Support laboratory investigations, change controls, and CAPAs related to QC operations.
Within 12 Months, You Will:
Contribute to budget planning and resource allocation for the Quality Control department.
Provide essential testing data and quality-related information to support product studies and stability programs.
Collaborate with other departments, such as AS&T, Quality Assurance, and Regulatory Affairs, for method transfer and qualification activities.
Here’s What You’ll Bring to the Table:
Minimum education required: Bachelor’s Degree in a relevant scientific discipline.
Minimum experience required: 10 + years in applied industry experience; 4-6 years of management/supervisory experience.
Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs.
Previous supervisory experience is preferred, including testing scheduling and lab project management.
Minimum knowledge required: general laboratory operations, method acquisition, qualification.
Minimum skills required:
Technical writing.
Proficiency with Microsoft Office Programs.
Familiarity with electronic databases (e.g., LIMS, SAP, LMS).
Familiarity with QC operations including bioassay, chemistry, and microbiology.
HPLC Instrumentation/ Software experience is preferred.
Strong written and oral communication skills as well as organizational skills.
Knowledge of industry standards and guidelines, experience supporting compliance audits.
Demonstrated ability to work effectively under established guidelines and instructions.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Make banking a Fifth Third better®
We connect great people to great opportunities. Are you ready to take the next step? Discover a career in banking at Fifth Third Bank.
GENERAL FUNCTION:
Responsible for the continued development and implementation of the Bancorp's compliance programs and management of the related Compliance Managers and teams, including ensuring compliance with Federal laws and regulations and industry standards. This position is responsible for providing strategic leadership / direction / oversight regarding the Bancorp's compliance risk management programs, including policies, testing, reporting, and control framework. The incumbent is responsible for analyzing current and emerging regulatory trends and proposing and implementing recommendations or system solutions to mitigate identified risk. This position is also responsible for team member development and employee engagement.
Responsible and accountable for risk by openly exchanging ideas and opinions, elevating concerns, and personally following policies and procedures as defined. Accountable for always doing the right thing for customers and colleagues, and ensures that actions and behaviors drive a positive customer experience. While operating within the Bank's risk appetite, achieves results by consistently identifying, assessing, managing, monitoring, and reporting risks of all types.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
SUPERVISORY RESPONSIBILITIES:
Manage staffing of the Compliance teams to ensure optimal performance in meeting the Risk Management Division's goals and objectives by providing employees timely, candid and constructive performance feedback; developing employees to their fullest potential and providing challenging opportunities that enhance employee career growth; developing the appropriate talent pool to ensure adequate bench strength and succession planning; recognizing and rewarding employees for accomplishments.
Senior Compliance DirectorLOCATION -- Charlotte, North Carolina 28202Fifth Third Bank, National Association is proud to have an engaged and inclusive culture and to promote and ensure equal employment opportunity in all employment decisions regardless of race, color, gender, national origin, religion, age, disability, sexual orientation, gender identity, military status, veteran status or any other legally protected status.
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Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be tasked with the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. They will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.
Primary Duties:
Operational Quality Management:
Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
Collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).
Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
In partnership with the CQOL, the CQOM will develop skill sets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).
Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.
In collaboration with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.
Inspection Preparation and Management:
Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
Lead and support GCP inspections, worldwide. The CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.
Team up with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).
Contribute to the development and/ or revision of our Company policies, SOPs and training materials.
Develop the strategy for management/support for GCP inspections of our Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.
Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
In partnership with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.
Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.
Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.
Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
CAPA Management Support:
Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. Track all inspection CAPA and regulatory commitments and checks evidence of completion.
Ensure repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
Provide guidance and support for CCQMs regarding inspections at a country level sites that require a company headquarters input.
Other activities:
Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.
Education:
Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.
Experience:
Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
Experience with delivering effective CAPA management solutions.
Experience with risk management tools and processes within the clinical quality framework.
Skills:
Superior oral and written communication skills in an international environment.
Ability to manage and develop others, including formal performance management when required.
Excellent project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Lead cross-functional teams of business professionals within and outside our Research Division.
Act urgently for worldwide health authority inspection matters.
Analyze, interpret and solve complex problems.
Think strategically and objectively and with creativity and innovation.
Effectively interact with all levels of specialists & management and exert influence to achieve results.
Identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.
#EligibleforERP
MRLGCTO
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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Expected salary range:
$135,500.00 - $213,400.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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Job Posting Title: Director, Test Administration Honoraria Management
College Board – Assessment Delivery Operations
Location: Remote or Hybrid options available
Type: This is a full-time position
About the Team
The Operations Division at College Board is focused on leading the organization’s transformation to support delivery of digital assessments. The division aims to provide a strong customer engagement and world-class digital assessment delivery experience that supports millions of students and thousands of schools and test centers annually. The 70-person Assessment Delivery department is a combination of sub-teams that support Test Administration Management, Supply Chain & Logistics, and Publications and Content Management. This role will be a Director on the Test Administration Management Onboard team.
About the Opportunity
As Director of Test Administration Management (TAM) Honoraria, you will apply your business development, financial expertise, vendor management, and operational proficiency to manage the operational function within Assessment Delivery Operations (ADO) responsible for the disbursement of honoraria payment to test administrators. You will support the TAM Onboard function, playing a pivotal role in managing and enhancing payment channels for our customers. This position requires a banking and online payment processing background, a focus on exceptional customer service, and a commitment to optimizing operational financial methods. You will apply innovative ways of thinking and operating by reimagining and evolving the honoraria process to enable greater agility, system automation, and higher levels of quality and efficiency for on-time payment delivery.
The candidate will be responsible for developing an efficient process for institutions to apply honoraria expenses and for facility fee exceptions as part of the administration of the SAT. We seek a candidate who will manage the relationship with and performance of our payment vendor and support our primary external customers (e.g., Test Center Coordinators and their staff).
As the main point of contact, you will collaborate closely with the payment vendor supporting the Test Center Coordinator and staff to ensure their needs are met and their experience is constantly improved. You will advocate for the end customer by leading changes and identifying and envisioning the backlog of features required to build greater efficiency and higher levels of quality. This requires strong and consistent partnership with multiple teams including College Readiness Assessments (CRA), Finance, Cost Management, Product Owners, Technology, Salesforce, Payment Vendor (PV), and PV's Customer Support team to understand and prioritize the Honoraria features and fully develop and validate success criteria. In addition, you will oversee and manage the daily intake, investigation, and resolution of PV escalations and work to drive enhancements to the coordinator experience. You will coordinate seamless handoffs among your team to others in Operations and work closely with the PV and Finance. The stakes are high -- flawless application of policies and processes with the highest degree of quality and speed across a wide array of issue types is of mission-critical importance to our brand.
In this role, you will:
Lead Daily Functions for Honoraria Capability (50%)
Partner with the Operations Vendor and Change Management (VCM) team for successful implementation of a new Honoraria payment vendor, including managing new test center staff onboarding honoraria processes, developing an online web strategy of honoraria content, and reviewing assessment survey feedback to enhance and identify payment issues
Ensure timely and accurate payments to honoraria recipients
Work with PV to ensure compliance with CRA policies to mitigate and reduce costs
Oversee and maintain efficient payment channels for honoraria distribution domestically and internationally
Continuously assess and improve payment methods to enhance the customer experience
Develop and maintain payment operations procedures for efficiency and compliance
Collaborate with cross-functional teams to streamline billing and payment workflows
Stay up to date with banking industry trends and best practices
Provide exceptional customer service to honoraria recipients who have escalated to PV, addressing inquiries and resolving payment-related issues promptly and professionally
Develop and maintain strong working relationships with PV, CRA, Finance, Treasury, Cost Management, and ADO, understanding their unique needs and requirements
Partner with Product Owners across the organization to continually evolve the core capabilities of critical functions
Conduct Analysis and Recommend Improvements (25%)
Analyze honoraria data to identify trends and opportunities for cost savings and efficiency improvements
Prepare honoraria reconciliation reports, forecasts, and budget analyses to support decision-making
Develop and implement risk management strategies to safeguard data
Identify process bottlenecks and inefficiencies and recommend solutions to streamline operations
Provide Strategic Support (25%)
Champion the roadmap connected to honoraria needs and influence the priority of features necessary to continually drive the function to new levels of optimization
Utilize a data-driven approach and skilled communication tactics to influence change agents and business owners across the organization, including ADO, Vendor Management, Technology, and CRA, to ensure registration operation priorities are understood and align with broader goals and objectives
About You
You have:
A minimum of 5 years of experience in financial analysis, billing operations, accounts payable, vendor management, or a related role
Knowledge of banking regulations, payment processing, and financial systems
Strong knowledge of operations management practices, compliance, and vendor management
Excellent interpersonal and customer service skills with a commitment to delivering a high level of service
Excellent verbal and written communication skills, including the ability to confidently interact with executives and other key leaders across the College Board and its partners; also includes the ability to facilitate meetings and present remotely and in-person to groups of 15 or more
A proven ability to lead complex and critical initiatives by clarifying objectives, planning, coordinating actions, managing issues, and communicating status and results to stakeholders at various levels of an organization
Comfortable working with business owners, product development teams, vendors, technology, and the proven ability to earn the trust of key stakeholders quickly; mobilize and motivate teams and resolve conflict
Experience in successfully gathering and analyzing data to predict trends and forecasting to address business problems in collaboration with diverse stakeholders
Proficiency in financial modeling, data analysis, and Microsoft Excel
Strong experience with Agile methodologies
Experience with Salesforce and SmartSheet preferred
Ability to adapt to changing priorities, thrive in a fast-paced environment, and execute with limited information and ambiguity
The ability to travel 4-6 times per year. Occasional travel is required to College Board offices and vendor site when needed (approximately once per quarter to College Board's Reston office, on an as-needed basis to other College Board or partner offices)
Bachelor's degree in finance, business, or a related field preferred
You are eligible to work in the U.S.
About Our Process
Application review will begin immediately and will continue until the position is filled
While the hiring process may vary, it generally includes: resume and application submission, recruiter phone screen, hiring manager interview, performance exercise and/or panel interview, and reference checks. This is an approximately 8-week process
About Our Benefits and Compensation
College Board offers a competitive benefits and compensation program that attracts top talent looking to make a difference in education. As a self-sustaining non-profit, we believe in compensating employees equitably in relation to each other, their qualifications, their impact, and the relevant market.
The hiring range for a new employee in this position is $80,000 to $130,000. College Board differentiates salaries by location so where you live will narrow the portion of this range in which you can expect a salary.
Your salary will be carefully determined based on your location, relevant experience, the external labor market, and the pay of College Board employees in similar roles. College Board strives to provide our best offer up front based on this criteria.
Your salary is only one part of all that College Board offers, including but not limited to:
A comprehensive package designed to support the well-being of employees and their families and promote education. Our robust benefits package includes health, dental, and vision insurance, generous paid time off, paid parental leave, fertility benefits, pet insurance, tuition assistance, retirement benefits, and more
Recognition of exceptional performance through annual bonuses, salary growth over time through market increases, and opportunities for merit raises and promotions based on increased scope of responsibility
A job that matters, a team that cares, and a place to learn, innovate and thrive
You can expect to have transparent conversations about benefits and compensation with our recruiters throughout your application process.
About Our Culture
Our community matters, and we strive to practice and improve our culture daily. Here are some headlines:
We are motivated to positively impact the educational and career trajectories of millions of students a year
We welcome staff to join any or all six of our affinity groups: ARISE (Alliance for Asian Retention, Inclusion, Success, and Engagement; DIASPORA (Alliance for Pan-African Success and Achievement); Pride (alliance for LGBTQ+ staff and allies); Resilience (alliance for Native staff and advocates); SALSA (Staff Alliance for Latinx Success and Achievement); and WIN (Women’s Impact Network)
We value learning and growth; we offer formal and informal ways to lead through your superpowers, sharpen your strengths, and meet your development goals
We offer a transparent approach to promotions and merit raises, annual performance-based bonuses, and how to grow your career here over time
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The roles and responsibilities of a quality assurance varies across different industries. The duties include regulate, arrange and concur on quality procedures, standards and specifications, assess requirements and ensure everything is complied.
The type of jobs related to quality assurance encompass analyst, associate, maintenance technician, audio & video equipment technician, manager of quality assurance, quality assurance assistant manager, quality engineer, quality assurance technician, maintenance manager, safety technician, HVAC technician, consultant, coordinator, director, quality inspector, field service engineer, specialist and supervisor.
The role of quality control is to examine products and materials for defects or deviations from specifications. Responsibilities include monitor operations to ensure that they meet production standards, recommend adjustments to the assembly process, test products being produced, discuss inspection results and report inspection.
The role of quality assurance is to ensure a product or service meets the established standards of quality including reliability, usability and performance required for distribution. Responsibilities include devise sampling procedures, review the implementation of inspection system, document internal audits, investigate customer complaints, compile statistical quality data and analyse data to identify areas of improvement in the quality system.
The role of quality assurance/quality control(QAQC) engineer is to work with quality assurance supervisors, analysing manufacturing processes for improvement using various methods of testing and inspection. Responsibilities include implementing methods for process control, promote quality standards, assist in process certification and review suppliers purchase orders while establishing supplier quality requirements.
The role of QC inspector is to monitor the quality of incoming and outgoing products for a company. Responsibilities include reading blueprints to understand the requirements of products/services, measure product dimensions, recommend improvements to the production process to ensure quality control, document inspection outcomes by completing detailed reports, advise production team about quality control concerns to improve product excellence and supervise the production process.
