The Director Product Quality Lead, Quality Assurance oversees and ensures the quality of our commercial biological product. The role involves managing all quality aspects of the product lifecycle, from production to post-market surveillance, ensuring compliance with regulatory requirements and internal standards. This role requires a strong background in biological products, quality assurance, and regulatory affairs, as well as proven experience in team management and leadership. The role involves developing, approving, monitoring, and maintaining critical quality standards to proactively minimize product quality risks. The individual will ensure quality management and lifecycle management, leading improvement initiatives in alignment with current regulatory expectations. The PQL is a key member of the product team and will partner 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. The Director Product Quality Lead as a manager leads the Product Quality sub-team dedicated to the program.
Here's What You'll Do:
Provide quality oversight and guidance throughout the CMC lifecycle management, focusing on operational excellence and strategic alignment with department goals.
Coordinate and support regulatory submissions and responses to regulatory inquiries, ensuring alignment with quality standards.
Develop and implement policies, SOPs, standard reports, and KPIs in collaboration with senior management for effective process verification and control strategy.
Identify and escalate significant quality risks, collaborating with senior management to implement timely mitigation strategies.
Represent Quality in cross-functional forums, providing support and oversight to internal manufacturing and testing facilities.
Manage quality aspects of product lifecycle activities within the team, including change control, deviations, and product recalls.
Lead the execution of the APQR process within the department, ensuring compliance with global standards.
Collaborate with cross-functional teams to support product development and commercialization, ensuring quality alignment.
Drive or support significant changes and issue management (Deviations/CAPAs) within internal manufacturing and testing sites.
Coordinate quality activities related to product launch within the QA team.
Contribute to improvement initiatives within the Quality Assurance team.
Support the development of policies and procedures within the Quality Assurance team, in collaboration with quality system business process owners.
Lead, mentor, and develop a team of quality professionals, ensuring alignment with department goals and fostering a collaborative work culture.
Here's What You'll Bring to the Table:
Education: Bachelor's Degree
Experience: STEM degree with 10-20 years' industry experience or a Master's degree with 8-15 years' industry experience, advanced degree preferred
Other Quantifiable Preference:
Extensive experience in biopharmaceutical & GMP.
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.
Experience in management or application of quality systems and e-systems in a biopharma organization.
Strong scientifically with technical expertise to ensure robust analysis of complex data and ability to make scientifically sound quality risk-based recommendations.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • Discretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
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 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
