Manager, Quality Assurance for Quality Control, UK

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas 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.

Modernas mission is to establish a leading-edge research development and manufacturing facility at Harwell as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic NHS and government partners across the UK. Were looking for global experts eager to join us in this endeavour contributing to a future where access to life-saving vaccines is a reality for all.

As Manager Quality Assurance for Quality Control (QA for QC) you will provide comprehensive quality oversight for QC activities at our UK manufacturing sitesprimarily the Harwell facility. Youll serve as a critical member of the Quality Assurance function ensuring that all QC operations align with cGMP global regulations and internal Moderna standards. This is an opportunity to help shape a strong quality culture support complex lab operations and contribute to Modernas mission by enabling a reliable and compliant analytical framework across our expanding global network. Youll also play a central role in embedding inspection readiness into daily operations and have the chance to work with international sites including Norwood Madrid and key external testing partners. As part of Modernas cutting-edge work in mRNA manufacturing this role also provides opportunities to engage with emerging technologies including digital tools and platforms that accelerate compliance and decision-making.

Heres What Youll Do:

Your key responsibilities will be:

• Provide strategic and operational quality oversight to QC laboratories at Harwell aligned with Modernas global quality framework.

• Ensure QC methods processes and SOPs are scientifically robust validated and aligned with regulatory expectations (e.g. ICH Q2 (R2) USP/Ph. Eur.).

• Lead the QA review and approval of laboratory-related documentation such as SOPs analytical reports Annual Product Quality Reviews and trend analyses.

• Oversee qualification validation and transfer of analytical methods to internal and external labs ensuring lifecycle management and scientific integrity.

• Support continuous GMP compliance by ensuring adherence to Good Documentation Practices and Data Integrity standards.

• Oversee and support OOS/OOT investigations to ensure they are prompt unbiased scientifically justified and concluded with effective CAPAs.

• Conduct on-the-floor QA oversight via lab walkthroughs data reviews and staff coaching.

Your responsibilities will also include:

• Lead inspection readiness efforts and actively participate in hosting MHRA FDA and other regulatory inspections.

• Monitor training qualification and competency records for QC personnel to ensure compliance.

• Perform risk-based QA decision-making using ICH Q9 principles.

• Oversee quality aspects of external/contract laboratories including qualification and performance monitoring.

• Execute trend analysis of QC data and verify CAPA effectiveness.

• Maintain alignment with other Moderna labs (Norwood Madrid Resilience sites) and ensure harmonization where possible.

• Foster an inclusive and quality-focused team culture that values collaboration and continuous improvement.

• Ensure task execution follows internal SOPs and global policies precisely and compliantly.

• Participate in on-call rotations or shift coverage when required to support 24/7 manufacturing operations.

• Additional duties as assigned in alignment with evolving site priorities.

The key Moderna Mindsets youll need to succeed in the role:

• We behave like owners. The solutions were building go beyond any job description.
  This role requires you to take full ownership of QC oversightsupporting lab staff influencing documentation practices and escalating critical issuesall with a proactive and leadership-driven mindset. You will represent QA in cross-functional environments and be seen as a trusted authority.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  With Modernas strong focus on innovation this role offers opportunities to adopt digital quality systems and analytics platforms to enhance compliance and drive more agile decision-making in QC oversight.

Heres What Youll Need (Basic Qualifications):

• Education: Bachelors Degree in a scientific field.

• Experience: 8 10 years of Biopharmaceutical / Pharmaceutical Industry within Quality.

• As part of Modernas commitment to workplace safety this role may require an enhanced pre-employment check.

Heres What Youll Bring to the Table (Preferred Qualifications):

• Strong working knowledge of cGMP regulations ISO standards and other relevant regulatory guidance document.

• Experience with regulatory inspections as a Subject Matter Expert (SME) including direct interactions with worldwide health authorities.

• Demonstrated experience in analytical or microbiological method validation.

• Experience with OOS/OOT investigation management risk management and digital quality systems.

• Strong leadership skills with ability to develop mentor and motivate diverse teams.

• Excellent project management organizational and communication skills.

• Experience interacting with regulatory authorities during regulatory inspections.

• Demonstrated ability making risk-based decisions.

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work at home and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness nutrition and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savingsandinvestments
• Location-specific perks and extras!

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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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.

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit 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 committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons 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. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .

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