QA Operations Head

Posted 16 Days Ago
Be an Early Applicant
2 Locations
Senior level
Healthtech • Biotech
The Role
As the QA Operations Head at Moderna, you will lead a team ensuring compliance and operational excellence in mRNA drug substance manufacturing while driving quality initiatives and continuous improvement.
Summary Generated by Built In

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's 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. We're looking for global experts eager to join us in this endeavor, contributing to a future where access to life-saving vaccines is a reality for all.​

As a Quality Assurance Manager at Moderna’s Harwell site, you will be a key leader in ensuring compliance, quality oversight, and operational excellence for the manufacturing of cGMP mRNA drug substances and drug products. You will lead a team of quality professionals and play a critical role in providing real-time quality oversight of manufacturing operations. Your ability to act with dynamic range—balancing hands-on quality management with strategic leadership—will be essential to success in this role. This is an opportunity to work within a cutting-edge facility and make a tangible impact on Moderna’s expanding quality and compliance initiatives in the UK.

Here’s What You’ll Do

Your key responsibilities will be:

  • Lead and manage a team of Quality Assurance professionals responsible for On-the-Floor manufacturing oversight, Deviation Management, Change Management, Batch Record Review, and Product Disposition.

  • Provide hands-on support in real-time quality oversight of manufacturing operations.

  • Ensure strict adherence to current Good Manufacturing Practices (cGMPs), standard operating procedures (SOPs), and manufacturing documentation.

  • Monitor key quality system metrics and process indicators, ensuring compliance with regulatory requirements and internal performance expectations.

  • Actively participate in tiered governance supporting performance objectives, including quality, delivery, and safety.

Your responsibilities will also include:

  • Serve as a role model for Quality Culture and the Moderna Mindsets, fostering collaboration with cross-functional partners and leadership teams.

  • Support the training, capability assessment, and professional development of the QA team.

  • Author, review, and approve SOPs, quality documentation, and compliance records to maintain regulatory adherence.

  • Drive continuous improvement initiatives across all aspects of quality management, ensuring streamlined operations and operational efficiency.

  • Represent Moderna in regulatory inspections and communications with health authorities, ensuring compliance with Good Manufacturing Practices (GMPs).

  • Ensure inspection readiness and provide guidance on regulatory matters.

  • Additional responsibilities as assigned.

The key Moderna Mindsets you’ll need to succeed in the role:

  • We act with dynamic range – As a Quality Assurance Manager, you will need to balance both strategic leadership and hands-on execution, driving high-level quality initiatives while directly supporting day-to-day manufacturing oversight.

  • We obsess over learning – Quality and compliance standards are constantly evolving. You will need to stay at the forefront of regulatory developments, continuously enhancing your team's expertise and ensuring that Moderna remains an industry leader in cGMP manufacturing and compliance.

This role presents a unique opportunity to contribute to Moderna’s global mission while shaping the quality culture at our state-of-the-art Harwell facility. If you are passionate about quality, compliance, and leadership in a fast-paced biotech environment, we invite you to join our team.

Here’s What You’ll Need (Basic Qualifications)

  • Bachelor’s Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience

  • 8 – 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

Here’s What You’ll Bring to the Table (Preferred Qualifications)

  • Demonstrated ability making risk-based decisions

  • Sterile drug product manufacturing experience preferred

  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at 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
  • Savings and investments
  • 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, 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. 

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 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 committed to equal opportunity in employment 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

We’re 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 [email protected]

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Top Skills

Good Manufacturing Practices
Quality Management Systems
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The Company
Cambridge, Massachusetts
6,848 Employees
On-site Workplace
Year Founded: 2010

What We Do

At Moderna, we believe messenger RNA, or mRNA, is the “software of life.”

Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease.

Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching and could meaningfully improve how medicines are discovered, developed and manufactured.

To learn more, visit www.modernatx.com.

This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762).

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