Associate Director, Product Quality Lead, Quality Assurance

at  Moderna

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 solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.
As the Associate Director, Product Quality Lead in Quality Assurance, you will oversee and ensure the quality of biological products within a franchise. This role involves managing all quality aspects of the product lifecycle, from clinical production, PPQ, submission, and launch to post-market surveillance, ensuring compliance with regulatory requirements and internal standards. You will leverage your strong background in biological products, quality assurance, and regulatory affairs, coupled with proven experience in matrix work and leadership, to drive improvement initiatives that align with current regulatory expectations. The Product Quality Lead (PQL) is a key member of the product team, partnering cross-functionally with teams such as Quality Assurance, Technical Development, Regulatory, Supply Chain, Manufacturing Sciences & Technology, Manufacturing, and Digital to enable efficient communication and strategic decision-making.

HERE’S WHAT YOU’LL DO YOUR KEY RESPONSIBILITIES WILL BE:

Providing quality oversight and guidance throughout the CMC lifecycle management, focusing on operational excellence and strategic alignment with departmental goals.
Coordinating and supporting regulatory submissions and responses to regulatory inquiries, ensuring alignment with quality standards.
Collaborating with fellow PQLs to align ways of working and standards across the organization.
Developing and implementing policies, SOPs, standard reports, and KPIs in collaboration with senior management for effective process verification and control strategy.
Identifying and escalating significant quality risks, collaborating with senior management to implement timely mitigation strategies.
Representing Quality in cross-functional forums, providing support and oversight to internal manufacturing and testing facilities.
Managing quality aspects of product lifecycle activities within the team, including change control, deviations, and product recalls.
Collaborating with cross-functional teams to support product development and commercialization, ensuring quality alignment.
Driving or supporting significant changes and issue management (Deviations/CAPAs) within internal manufacturing and testing sites.
Coordinating quality activities related to product launch within the QA teams.
Contributing to improvement initiatives within the Quality Assurance team.
Supporting the development of policies and procedures within the Quality Assurance team, in collaboration with quality system business process owners.

YOUR RESPONSIBILITIES WILL ALSO INCLUDE:

Leading and managing projects/teams of significant scope and complexity within Quality Assurance.
Engaging in practical experience with Quality Risk Management lifecycle.
Demonstrating a strong ability to navigate through ambiguity and rapid growth while adapting to change.
Implementing a ‘digital first’ and curious mindset to allow continuous learning and challenging of the status quo.
Ensuring robust analysis of complex data and making scientifically sound, quality risk-based recommendations.
Actively contributing to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

THE KEY MODERNA MINDSETS YOU’LL NEED TO SUCCEED IN THE ROLE:

We pursue options in parallel: By strategically aligning quality processes and standards, you’ll ensure that the best possible choices are available for decision-making.
We behave like owners: Taking full responsibility for the quality outcomes, you will guide your team with the same commitment as if it were your own enterprise.
Here’s What You’ll Need ( Basic Qualifications)
Education: Bachelor of Science degree in STEM
Experience: a minimum of 10 years of experience in pharmaceutical industry
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Significant experience in biopharmaceutical manufacturing/analytics.
Knowledge in risk management and quality system requirements.
Ability to work in a dynamic range from deep dive to establishing a big picture.
Proven ability to lead and manage projects/teams of significant scope and complexity.
Excellent interpersonal skills and a team-oriented approach to project management and problem-solving.
Outstanding communication skills (verbal and written).
Ability to navigate through ambiguity and rapid growth and adapt to change.
A ‘digital first’ and curious mindset that allows continuous learning and challenging the status quo.
Working knowledge of relevant FDA, EU regulations, and ICH standards/guidelines.
Practical experience with Quality Risk Management lifecycle.
Strong scientifically with technical expertise to ensure robust analysis of complex data and ability to make scientifically sound quality risk-based recommendations.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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:
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, and a discretionary year-end shutdown
Educational resources
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 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. 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 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 leavesandaccommodations@modernatx.com .