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Job Description
A wonderful opportunity has arisen to join the Ballydine site as Associate Director Quality Assurance. Reporting to the Quality Director, the incumbent will work with the Quality Leadership team to ensure compliance with all regulatory requirements for Drug Substance (DS), Spray Dried Intermediate (SDI) and Drug product (DP) released to downstream customer. This is a permanent role with opportunities for some home working.
Role Responsibilities
Qualification Requirements
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
N/A
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
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Job Description
Support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. Utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
This position is responsible for the execution of the global Quality Assurance audit activities on assigned studies, products, vendors and Country Offices. This role is accountable for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures, policies, and all applicable worldwide regulations and guidelines.
Primary activities include, but are not limited to:
Main requirements:
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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply 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:
25%Flexible Work Arrangements:
Shift:
1st - DayValid Driving License:
YesHazardous Material(s):
n/aOfficial account of Jobstore.
At Niagara, we’re looking for Team Members who want to be part of achieving our mission to provide our customers the highest quality most affordable bottled water.
Consider applying here, if you want to:
We offer competitive compensation and benefits packages for our Team Members.
Sr. Director of Quality AssuranceThe Sr. Director of Quality Assurance - Aseptic & Beverage is responsible for overseeing the sanitary process design, commissionings and quality systems of Niagara Aseptic and Beverage bottling facilities. This position must ensure all products and processes meet the required Food Safety and Product Quality Standards. This should include but not be limited to our Niagara Sanitation standards and policies for both Aseptic and Beverage bottling locations.
This position will provide quality and food safety oversight for Beverage and Aseptic projects including, but not limited to new beverage technologies, potential cost savings, efficiency improvements, CIP extensions, equipment retrofits, process improvements, new product rollouts, and other miscellaneous projects as dictated by customer needs. This position is also responsible for providing technical support to other cross functional departments, including scoping of new sales opportunities and ongoing customer discussions.
This position reports to the Vice President of Quality Assurance, Beverage.
Essential Functions
Qualifications
*Experience may include a combination of work experience and education
*Experience may include a combination of work experience and education
Competencies
This position embodies the values of Niagara’s LIFE competency model, focusing on the following key drivers of success:
Education
Certification/License:
Typical Compensation Range
Pay Rate Type: Salary$187,016.00 - $261,823.00 / YearlyBonus Target: 30% AnnualBenefits
https://careers.niagarawater.com/us/en/benefits
Any employment agency, person or entity that submits a résumé into this career site or to a hiring manager does so with the understanding that the applicant's résumé will become the property of Niagara Bottling, LLC. Niagara Bottling, LLC will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity.
Employment agencies that have fee agreements with Niagara Bottling, LLC and have been engaged on a search shall submit résumé to the designated Niagara Bottling, LLC recruiter or, upon authorization, submit résumé into this career site to be eligible for placement fees.
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Job Overview:
This position is for an Associate Quality Assurance Director in the Risk Analytics team who will serve as the strategic quality engagement leader focusing on risk analysis projects and tracking for each business function with primary focus on Clinical Operations. The role includes the following activities:
Responsibilities:
• Predominantly supports Clinical Operations globally.
• Provides actionable insights from risk analysis and operational data analysis and working with cross-functional stakeholder to develop action plans to drive continuous improvement.
• Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams
• Supports the management and resolution of significant issues relating to quality.
• In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
• Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
• Contributes to the development of the global risk-based internal audit plan.
• Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
• Prepares for and actively participates in relevant Governance/partnership level meetings e.g., Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
• Interfaces with senior management to discuss quality and compliance issues
• Interfaces with business development and operations to identify business opportunities
• Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.
Qualifications
• Bachelor's Degree Mandatory
• 8-10 years experience Quality Assurance experience preferably within a CRO space or related area that includes GCP Quality Assurance experience.
• Knowledge of Excel, spreadsheet, and eQMS platforms (SmartSolve is preferred).
• Strong knowledge of GCP quality standards.
• Considerable knowledge of quality assurance processes and procedures'.
• Strong interpersonal skills and the ability to positively influence and guide others.
• Excellent problem solving and risk/data analysis skills.
• Effective organization, communication, and team orientation skills.
• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
• Demonstrated ability to lead and manage multiple responsibilities.
• Identify functional constraints and identify solutions.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. We’re proud to offer many development and advancement opportunities to our nearly 50,000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint.
Work Shift:
8 Hours - Day Shifts (United States of America)Scheduled Weekly Hours:
40Union Position:
NoDepartment Details
Summary
Provide oversight of quality, performance improvement, and patient safety activities. Develop the vision and strategic plan for quality, safety and continuous improvement across the Enterprise.Job Description
Responsibilities include: budget management, allocation of appropriate resources and staffing, action plans, issue resolution, program development, education and mentorship of regional staff. Consults with senior leaders and frontline staff regarding error prevention strategies, advises on policies to encourage a culture of safety and design programs to deploy best practices in regard to increased error reporting and error reduction across the organization. Accountable to develop programmatic planning and project coordination to achieve the strategic goals of Sanford pertaining to quality, performance improvement and patient safety. Demonstrates the ability to analyze and synthesize complex or diverse information. Works well in group problem solving situations. Exhibits strong communication and presentation skills, and shows the ability to manage and coordinate project team activities. Effectively influences actions and opinions of others. Demonstrates understanding of clinical presentations of disease processes across the age spectrum. Demonstrates the ability to write clearly and concisely, communicating complex concepts accurately. Effectively presents information in a variety of venues and organizes communication systems necessary to achieve goals. Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Maintains an understanding of clinical presentations of disease processes across the age spectrum is necessary.
Qualifications
Bachelor's degree in nursing, public health, pharmacy, health administration, or other healthcare related field is required. Master's degree preferred.Sanford is an EEO/AA Employer M/F/Disability/Vet.
If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-877-673-0854 or send an email to talent@sanfordhealth.org.
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The Director of Quality Optimization will be responsible for leading strategic First Time Quality (FTQ) and Inspection Optimization initiatives, aimed at driving significant cost savings and process improvements through the optimization of inspection, sampling, and destructive testing methodologies.
Your role:
You're the right fit if:
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
Philips Transparency Details:
The pay range for this position is $154,000 to $264,000 annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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Non-CA Pay Range (Annual):
$143,600.00 - $266,800.00At Infinera, your base pay is one part of your total compensation package. Your actual base pay will depend on your skills, qualifications, experience, and location. This role may be eligible for equity grants, discretionary bonuses, or commission payments. The amount of these incentives is based on the terms of the Company’s incentive plans, the Company’s financial performance, and/or individual employee job performance.
Infinera also offers paid leave, medical,
dental, and vision coverage, 401(k), life, and disability insurance and to
eligible employees.
The R&D Quality Director role requires a unique blend of management and hands-on expertise, serving as a vital bridge between Quality and R&D. We are seeking a seasoned professional with over 20 years of industry experience, including substantial exposure to both software and hardware development. The successful candidate will lead a team of three quality managers, closely partnering with R&D to drive continuous improvements in product quality and processes. This pivotal role ensures that quality remains at the forefront of R&D efforts, fostering excellence across the entire organization.
Key Tasks & Responsibilities:
Secure Quality in Products & R&D Programs
Support R&D Process Management
Drive Continual Improvement
Value add:
KPIs:
Key interfaces:
Required Experience:
#LI-DW
#LI-Hybrid
Infinera is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Infinera complies with all applicable state and local laws governing nondiscrimination in employment.
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Proud member of the Disability Confident employer scheme
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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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Position: Director of Quality
Team: Managed Investment Data Team
The Role
The pursuit of quality at Morningstar is deeply ingrained in our culture and it is a key part of the value we bring our clients. We seek a highly self-motivated professional to own the strategic roadmap for continuous improvement of Managed Investment Data. The Director of Quality leads a team responsible for developing, implementing and monitoring quality assurance programs and ensures effective and efficient policies, processes, and procedures in place and adhered to. The Director of Quality will create a culture of client-centric quality, where all data quality goals are from the perspective of the user. The Director of Quality will collaborate with peers in the same role for other data types at Morningstar to drive global best in class data quality. This role will also work closely with audit and benchmarking Data team leaders and global stakeholders to ensure that all the agreed deliverables from the team are met, and that the team is fully equipped in terms of training and documentation. This role reports to the Head of Managed Investment Data.
Responsibilities:
• Measure, build, sustain, and own the quality framework and processes across the Managed Investment content set that help us deliver quality data to clients.
• Build and lead an internal data quality team emphasizing content expertise and client-centric measurements of quality.
• Own the success of the quality health review and certification program.
• Aggregate data quality metrics and deliver holistic data health updates to internal stakeholders, with action plans for continued success.
• Own the data quality testing suites. Define the priority of future testing suites for Data Technology. Establish an operating model in which we proactively identify bugs and introduce new tests for each bug identified and for all new developments
• Oversee the management of day-to-day activities of team to develop and implement the quality framework of key global Managed Investment database.
• Accountable for ensuring and improving the performance, productivity and efficiency of the teams and the delivery of the operational performance KPIs, for team engagement, morale, and supporting the build for growth ladders of members.
• Serve as an escalation point for critical quality assurance issues.
• Partner closely with Data Operations team leaders to conduct root cause analysis, and track implementation of process improvements based on findings and measure impact
• Define requirements for quality dashboards for Managed Investment Data and collaborate with the Enterprise Data Platform team and other Quality Directors to bring these dashboards into a consistent data quality dashboard.
• Define metrics to assess the effectiveness of our quality testing suites
• Partner with the Director of Customer Support to identify data quality defects via patterns in client tickets and establish test cases to mitigate future defects.
• Identify and prioritize auditing and benchmarking opportunities across Managed Investment Data. Coordinate with the central auditing and benchmarking team to have them scheduled. Monitor progress of executing on action items after the audit RCA.
• Monitor the industry for quality control methods and propose future areas of investment for Morningstar to reach and sustain best in class quality.
Requirements:
• A broad and comprehensive understanding of investment and financial data sets.
• Bachelor’s degree and 10+ years of experience in quality assurance, including experience with LEAN, Six Sigma, and Kaizen.
• 5+ years of experience managing a team
• 5+ years of experience working directly with data technology squad(s).
• Demonstrated ability to partner with product managers to understand the needs of the user and translate those user needs into data quality goals
• Demonstrated ability to write and execute SQL queries.
• Excellent communication skills. Demonstrated ability to communicate complex data matters correctly and clearly to internal and external consumers.
Preferred Qualifications
• Certified Lean Six-Sigma Green or Black Belt.
• Experience with data visualization software, such as Microsoft Power BI and Tableau.
• Experience managing a global team.
I10_MstarIndiaPvtLtd Morningstar India Private Ltd. (Delhi) 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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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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Functional Competencies:
Requirements:
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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.
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.
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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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Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
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25%Flexible Work Arrangements:
RemoteShift:
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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.
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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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