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Job Description
Calling all passionate quality leaders! Join us as Associate Director & Qualified Person and make a significant impact on the success of our global clinical supply chain!
This pivotal role lets you build and lead a team, ensuring the flawless delivery of life-changing medicines worldwide.
Join us and make a real difference in patient lives.
Purpose of the position
In this crucial role, you'll directly support the Director, GDQ (Global Development Quality), by ensuring the smooth operation of our global clinical supply chain. You'll achieve this by overseeing all activities related to the disposition of clinical finished goods used in our worldwide trials. This includes building a dedicated team of two Senior QA Specialists at our Haarlem site.
Your primary focus will be ensuring the quality and compliance of investigational medicinal products (IMPs) throughout our Global Clinical Supply (GCS) Warehouse and Distribution network. You'll achieve this by overseeing all quality assurance activities related to Good Manufacturing Practice (GMP) compliance for the IMP license. Additionally, you'll design and manage a robust Quality Management System (QMS) for the clinical supply warehouse and distribution functions.
To maintain a seamless global clinical supply chain, you'll manage the distribution, and final disposition of clinical finished goods. This collaborative role will require you to work closely with internal and external partners to guarantee the on-time delivery of cGMP-compliant clinical supplies worldwide. You'll also be the company's voice during regulatory inspections pertaining to the IMP license and QMS.
Welcome to our team
The Global Development Quality (GDQ) organization is responsible for providing quality oversight of internal clinical packaging and distribution operations and supply chain management support for the end-to-end clinical supply chain.
Our team partners broadly across our company and our external partners to deliver continuous current good manufacturing practices (cGMP)-compliant clinical supply on time, every time, across the globe.
Primary responsibilities
Act as Quality site lead / QP for quality aspects of warehousing and distribution activities at the site in Haarlem.
Provide QP certification of batches of IMPs packaged for Clinical Trial use as required by directive 2001/20/EC.
Drive the implementation of the quality strategy at site.
Oversee the recruitment, management and development of the Quality team.
Lead the departmental and site preparation for internal and external audits
Champion the continuous improvement of the quality strategy by prioritizing, initiating and monitoring related improvements.
Legally responsible for the executions of releases and the execution of potential recalls.
Your profile
Master's degree in science or Pharmacy qualification (QP eligible).
6-8 years in pharma Quality Assurance, ideally with manufacturing & logistics experience.
Several years of experience as a Qualified Person (QP).
Strong team leadership & coaching skills.
Proven ability to analyze, recommend & lead quality initiatives.
Excellent communication with strong analytical thinking and EU GMP/cGMP knowledge.
Fluency in English (written & spoken)
Travel willingness (up to 10%)
What we offer
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
Competitive salary and a 3% year-end bonus;
35,5 days of leave;
Attractive collective health care insurance package with considerable reduction rates;
Solid Pension Plan;
Incentive Plan;
Travel allowance for commuting;
On-site sports facilities
Numerous training, coaching and e-learning modules for long term job opportunities and development
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
The Role
Reporting to the Executive Director of Digital Quality, the Director, Technical Program Management, Digital Quality will be responsible for the deployment and continuous improvement of our digital platform systems/instruments supporting our Global Quality Control.
Moderna is a cloud-first company, and this role will balance building strong foundations, with implementing innovative new solutions that drive business value. This position will play a key role partnering with Quality Control stakeholders and peers to enable our systems and processes.
Under Resilience and INT programs, Moderna is expanding manufacturing & laboratory operations to additional global sites such as Australia (Clayton), Canada (Laval) and the UK (Harwell). Digital Quality systems (Instruments, Enterprise & Local Systems, etc.) are required to be extended, functional and qualified for the Operational Readiness of each site.
Who You Are:
You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. You thrive in a fast-paced environment and are comfortable rolling up your sleeves – if a process doesn’t exist yet, you define it.
Here’s What You’ll Do
Lead and manage a team of engineers designing and implementing the digital quality systems and instruments that will be deployed at the global Moderna Laboratories/Sites (Norwood, Madrid, Laval, Clayton etc.)
For Project Resilience and INT lead the execution of the Digital Quality workstream proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines. Ensure that the in scope digital systems for each site deployed on time to support site qualification and method transfer to QC. Engage with the system owners to ensure that an appropriate support structure is in place to support each system at each site.
Lead the execution of complex, integrated projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines.
Partner closely with key business stakeholders to understand their processes and deploy solutions to measurably support the business need.
Engage with digital quality team members and system owners in the US to ensure to maintain consistency in the systems or instruments while meeting the needs of the local business stakeholders.
As a member of the Digital Quality LT work partner with peers to lead the DQ team, to drive the success of ongoing efforts and implement improvement projects to meet evolving business needs.
Work with and provide input to digital management to develop and maintain a multi-year roadmap of key capabilities aligned with business strategy.
As required participate with digital leadership teams to implement efforts and improvement projects to meet evolving business needs.
Ensure GMP compliance is prioritized in the design, delivery, and maintenance of all systems.
Serve as a change agent to engage and educate the business owners on the capability and functionality of digital solutions.
Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems.
Here’s What You’ll Need (Minimum Qualifications)
Bachelor’s degree or equivalent in science, engineering or computer science, MBA or PhD is a plus.
8 - 10 years’ experience designing and implementing systems in the laboratory (ideally experience with instrument deployment, LIMS, CDS etc.) working in a GMP environment
Compliance focused mindset
Strong understanding of core laboratory system workflows
Strong understanding of laboratory systems including data integrity regulations, instrument integration and laboratory digital workflow optimization
Ability to adapt to a fast changing, startup like environment.
Experience in defining, scoping, and managing technology initiatives.
Strong knowledge GAMP and GXP compliance regulations
Ability to effectively communicate with all levels within the organization.
Ability to lead and motivate teams to reach a common goal.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Creative/innovative/problem solver that actively drives progress
Ability to work independently and make sound and timely decision to achieve expected results
Strong understanding of core laboratory systems, related processes, and quality management workflows
Strong interpersonal skills with the ability to build successful professional working relationships
Ability to participate on multiple concurrent projects in a fast-paced environment.
Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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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Your opportunity
IQVIA, a leading Human Data Science company, is seeking a dynamic and experienced Senior Director of Compliance to join our Ethics and Compliance Office (ECO). In this critical leadership role, you will shape and maintain an effective healthcare compliance program on a global scale. Your responsibilities will span a wide range of duties, ensuring adherence to ethical standards and regulatory requirements.
You will interact regularly with various internal stakeholders, including Legal, Finance, Human Resources, Internal Audit, Global Quality Assurance, Chief Information Office, and all global and regional business units, as well as with external parties such as auditors, law firms, and regulators.
As a leader, you will be a trusted member of the ECO Leadership Team, managing at least one employee and reporting to the Chief Compliance Officer, and driving a culture of ethics and integrity in all we do.
Your key responsibilities will include:
Strategic Leadership:
Oversee IQVIA’s Code of Conduct and ethics and compliance policies.
Manage the Ethics Line, including the Ethics Line mailbox, in accordance with applicable laws and best practices.
Prepare materials for presentations to IQVIA’s senior leadership, Audit Committee, and external auditors.
Provide expert guidance to internal stakeholders across Legal, Finance, Human Resources, and other departments.
Conduct sensitive investigations as needed.
Collaboration and Stakeholder Management:
Interact regularly with internal teams, including Legal, Finance, Internal Audit, and Global Quality Assurance.
Build collaborative relationships with external parties such as auditors, law firms, and regulators.
People Leadership:
Manage at least one employee.
Report directly to the Chief Compliance Officer.
Drive a culture of ethics and integrity throughout the organization.
To be successful on this role, you will have qualifications such as:
Subject Matter Expertise:
Stay informed about global laws, regulations, and codes of ethics.
Provide guidance to leadership, management, and employees.
JD preferred, or Masters’ degree in legal relevant area, and at least 10 years of relevant experience.
Sound knowledge and understanding of the legal and regulatory environment in which the company operates; life sciences or healthcare compliance expertise.
Ethics Line Management:
Experience managing an ethics reporting line, maintaining data and analytics, and preparing accurate, compelling presentations for a wide range of audiences including executive leadership, Audit Committee of Board of Directors, external auditors, and regulators in different regions and countries.
Ensure compliance with EU whistleblower laws and other relevant regulations.
Risk Assessment:
Utilize deep subject matter knowledge to assess risks across various areas.
Experience managing Codes of Conduct and corporate policies.
Experienced investigator; able to guide investigations and enhance capabilities for various resources who do not regularly conduct investigations.
Excellent analytical and problem-solving skills; ability to synthesize and summarize complex issues.
Excellent judgment and discretion, including the ability to handle sensitive and/or confidential information.
You will differentiate yourself if you have:
Relevant compliance or professional certification: Certified Compliance and Ethics Professional (CCEP), Certified Fraud Examiner (CFE).
Life sciences outsourcing experience (e.g., CRO).
Location
IQVIA currently offers remote work arrangements.
The incumbent must be based anywhere on the East Coast of the United States.
How to Apply
If you are a seasoned compliance professional with a passion for ethics and integrity, we invite you to be part of our mission to advance healthcare through data science. Apply now by visiting our careers page and searching for Job ID R1393190.
We look forward to welcoming a dedicated leader to our team! 🌟
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
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $156,700.00 - $293,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.Official account of Jobstore.
Job: Title: Associate Director of Quality Assurance (GCP)
Salary: Competitive
Location: York (Hybrid role)
SRG are supporting a global clinical lab services company in their search for an Associate Director of Quality Assurance.
The successful Quality Assurance Lead will be responsible for implementing strategies to allow successful delivery of high-quality Clinical Trials studies; by driving effective, efficient, global processes across the various aspects of our Quality and Operations.
Responsibilities:
Requirements:
If you are interested in finding out more, please apply using the provided link or send a copy of your CV directly to Alex Sheridan on or contact Alex directly on 0203 854 5418 for a confidential conversation.
SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
Official account of Jobstore.
In-Office Requirement:
The U.S. Postal Service, Office of Inspector General values collaboration, teamwork, and effective communication to foster our dynamic working and learning environment. The position adheres to our agency's telework policy to facilitate this and requires an in-office presence of at least two days per pay period. Remote work is not available for this role.
About the Cybersecurity & Technology Directorate:
The U.S. Postal Service's mission is to bind the nation together through the delivery of mail and to provide prompt, reliable, and efficient postal services to all communities each day. The USPS OIG conducts systematic performance, financial, or attestation reviews and audits of U.S. Postal Service programs and operations, including assessments of efficiency and adequacy of internal controls; compliance with laws, regulations, policies, and/or contracts; and detection of fraud, waste, and abuse.
The Cybersecurity & Technology Directorate helps reduce the risk of fraud, inappropriate disclosure of sensitive data, and disruption of critical postal operations and services by assessing whether USPS information resources provide the highest level of security, reliability, and value expected by USPS customers.
To learn more about the Office of Audit, visit: United States Postal Service, Office of Inspector General - Office of Audit
The USPS OIG uses a Pay Banding system, which is equivalent to the Federal GS scale. Grade and salary determinations will be made based upon a candidate's education and professional experience.
This position is being advertised at the Journey Band level, equivalent to a GS-07/09. The salary range for this position is $48,247.00 - $84,441.00. The salary figures INCLUDE locality pay. Review OPM's site for Locality Table specifics: 2023 General Schedule (GS).
Career Advancement Opportunities: Non-competitive promotion up to a GS-13 equivalent level is possible through our career ladder program.
The GS-07 equivalent is at the trainee level in the area of information technology analysis. The employee serves as a junior member of an audit team assisting with systematic performance, financial, or attestation reviews and the OIG's Office of Audit information technology programs and operations. Work assignments are selected to provide training in the analytical evaluative aspects of the work and in the appropriate use of qualitative and quantitative analysis methods and techniques. The training is directed toward the utilization of a wide range of information technology concepts, laws, policies, practices, analytical, and diagnostic methods and techniques. Assignments are selected to combine performance of productive work with supervised on-the-job training.
The following duties and responsibilities reflect the GS-09 equivalent role. See this announcement's requirements section for minimum requirements for each level.
The employee performs assignments requiring the application of fundamental principles, concepts, techniques, and guidelines in the area of information technology for the Audit team. Assignments are of average difficulty. The employee may participate in more complex studies and projects designed to develop broader expertise, utilizing a wider range of information technology concepts, laws, policies, practices, analytical, and diagnostic methods and techniques.
Successful candidates will have relevant experience in the following:
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VA offers a comprehensive total rewards package: VA Nurse Total Rewards
The Chief Nurse for Quality and Safety reports directly to the Executive Director and is accountable to the Associate Director Patient Care Services for Nursing specific practice and standards. The incumbent promotes quality improvement activities in collaboration with various services and individuals and suggests models for adaptation of implementation. The incumbent coordinates management policies and practices as they relate to quality improvement. Collaborates closely with Medical Center staff to examine and promote methods for achieving quality that may be new or applied in a different way.Duties include but are not limited to:
Official account of Jobstore.
In-Office Requirement:
The U.S. Postal Service, Office of Inspector General values collaboration, teamwork, and effective communication to foster our dynamic working and learning environment. The position adheres to our agency's telework policy to facilitate this and requires an in-office presence of at least two days per pay period. Remote work is not available for this role.
About the Cybersecurity & Technology Directorate:
The U.S. Postal Service's mission is to bind the nation together through the delivery of mail and to provide prompt, reliable, and efficient postal services to all communities each day. The USPS OIG conducts systematic performance, financial, or attestation reviews and audits of U.S. Postal Service programs and operations, including assessments of efficiency and adequacy of internal controls; compliance with laws, regulations, policies, and/or contracts; and detection of fraud, waste, and abuse.
The Cybersecurity & Technology Directorate helps reduce the risk of fraud, inappropriate disclosure of sensitive data, and disruption of critical postal operations and services by assessing whether USPS information resources provide the highest level of security, reliability, and value expected by USPS customers.
To learn more about the Office of Audit, visit: United States Postal Service, Office of Inspector General - Office of Audit
The USPS OIG uses a Pay Banding system, which is equivalent to the Federal GS scale. Grade and salary determinations will be made based upon a candidate's education and professional experience.
This position is being advertised at the Journey Band level, equivalent to a GS-07/09. The salary range for this position is $48,247.00 - $84,441.00. The salary figures INCLUDE locality pay. Review OPM's site for Locality Table specifics: 2023 General Schedule (GS).
Career Advancement Opportunities: Non-competitive promotion up to a GS-13 equivalent level is possible through our career ladder program.
The GS-07 equivalent is at the trainee level in the area of information technology analysis. The employee serves as a junior member of an audit team assisting with systematic performance, financial, or attestation reviews and the OIG's Office of Audit information technology programs and operations. Work assignments are selected to provide training in the analytical evaluative aspects of the work and in the appropriate use of qualitative and quantitative analysis methods and techniques. The training is directed toward the utilization of a wide range of information technology concepts, laws, policies, practices, analytical, and diagnostic methods and techniques. Assignments are selected to combine performance of productive work with supervised on-the-job training.
The following duties and responsibilities reflect the GS-09 equivalent role. See this announcement's requirements section for minimum requirements for each level.
The employee performs assignments requiring the application of fundamental principles, concepts, techniques, and guidelines in the area of information technology for the Audit team. Assignments are of average difficulty. The employee may participate in more complex studies and projects designed to develop broader expertise, utilizing a wider range of information technology concepts, laws, policies, practices, analytical, and diagnostic methods and techniques.
Successful candidates will have relevant experience in the following:
Official account of Jobstore.
In-Office Requirement:
The U.S. Postal Service, Office of Inspector General values collaboration, teamwork, and effective communication to foster our dynamic working and learning environment. The position adheres to our agency's telework policy to facilitate this and requires an in-office presence of at least two days per pay period. Remote work is not available for this role.
About the Cybersecurity & Technology Directorate:
The U.S. Postal Service's mission is to bind the nation together through the delivery of mail and to provide prompt, reliable, and efficient postal services to all communities each day. The USPS OIG conducts systematic performance, financial, or attestation reviews and audits of U.S. Postal Service programs and operations, including assessments of efficiency and adequacy of internal controls; compliance with laws, regulations, policies, and/or contracts; and detection of fraud, waste, and abuse.
The Cybersecurity & Technology Directorate helps reduce the risk of fraud, inappropriate disclosure of sensitive data, and disruption of critical postal operations and services by assessing whether USPS information resources provide the highest level of security, reliability, and value expected by USPS customers.
To learn more about the Office of Audit, visit: United States Postal Service, Office of Inspector General - Office of Audit
The USPS OIG uses a Pay Banding system, which is equivalent to the Federal GS scale. Grade and salary determinations will be made based upon a candidate's education and professional experience.
This position is being advertised at the Journey Band level, equivalent to a GS-07/09. The salary range for this position is $48,247.00 - $84,441.00. The salary figures INCLUDE locality pay. Review OPM's site for Locality Table specifics: 2023 General Schedule (GS).
Career Advancement Opportunities: Non-competitive promotion up to a GS-13 equivalent level is possible through our career ladder program.
The GS-07 equivalent is at the trainee level in the area of information technology analysis. The employee serves as a junior member of an audit team assisting with systematic performance, financial, or attestation reviews and the OIG's Office of Audit information technology programs and operations. Work assignments are selected to provide training in the analytical evaluative aspects of the work and in the appropriate use of qualitative and quantitative analysis methods and techniques. The training is directed toward the utilization of a wide range of information technology concepts, laws, policies, practices, analytical, and diagnostic methods and techniques. Assignments are selected to combine performance of productive work with supervised on-the-job training.
The following duties and responsibilities reflect the GS-09 equivalent role. See this announcement's requirements section for minimum requirements for each level.
The employee performs assignments requiring the application of fundamental principles, concepts, techniques, and guidelines in the area of information technology for the Audit team. Assignments are of average difficulty. The employee may participate in more complex studies and projects designed to develop broader expertise, utilizing a wider range of information technology concepts, laws, policies, practices, analytical, and diagnostic methods and techniques.
Successful candidates will have relevant experience in the following:
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