Sr. Manager, External Quality Control

The Role:

Reporting to the Director of External QC for the International Organization, the Senior Manager External QC will be leading a team responsible to provide operational support for QC activities at contract manufacturing and testing facilities to ensure compliance with internal policies, procedures, and regulatory requirements.

The Senior Manager External QC will provide support for testing activities including raw material, in-process, and release testing at contract manufacturing organizations (CMOs) for drug substance and drug product fill finish activities and oversight of Contract Testing Laboratories (CTLs) to ensure compliance and business needs are met. The incumbent will be responsible for driving QC

improvement initiatives, ensuring robust quality control processes are implemented across Moderna’s DP testing operations and will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.

Here’s What You’ll Do:

• Provide QC support for the review and approval of all cGMP documentation including policies/SOPs, analytical data, analytical test methods, analytical method transfer and validation protocols/reports, stability protocols/reports, specifications.
• Participate in cross-functional discussions to ensure changes in analytical standards are implemented consistently across the network
• Collaborate with Regulatory CMC, providing expert analytical input to relevant sections of the dossier to ensure submission timelines and regulatory commitments are met.
• Lead QC oversight of analytical method transfer projects at CMOs and CTLs and provide expert analytical input into the quality control strategy for commercial product.
• Lead the team providing guidance, establishing priorities, and ensuring operational support to all internal and external customers
• Provide oversight of end-to-end QC activities at external partners for new product introduction and implementation of significant analytical changes.
• Bring your QC expertise and proactive mindset to identify and execute improvement initiatives to ensure the external QC team can effectively meet all stakeholder demands.
• Collaborate with manufacturing and contract testing facility personnel and internal subject matter experts in Analytical, Science & Technology, Manufacturing, Science & Technology, QA Operations, QA Release and Supply Chain Planning to support ongoing operational activities and resolve issues related to QC testing.
• Lead complex laboratory investigations to resolution with external partners, CMOs, CTLs, National Testing Laboratories and manage internal escalations appropriately with cross-functional teams.
• Provide QC support for timely completion of all quality system records related to testing activities; OOS/OOT, Deviation, CAPA, and Change Controls.
• Take part in the Moderna Operations governance teams to ensure escalations are communicated and necessary actions are followed and tracked to completion

Here’s What You’ll Bring to the Table:

• Experienced in executing quality control testing, analytical method transfers and validation within a biotechnology industry.
• Experience working with CMOs, CTLs, vendors, and relationship management preferred
• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
• A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.
• Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
• Working knowledge of relevant US and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections.
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
• Ability to conceptualize, analyze, plan, and manage multiple projects in a fast-paced environment.
• A proven track record of success in managing analytical projects with external testing sites in a biopharma organization.
• 5 years management/supervisory experience in cGMP organization.
• Bachelor’s degree in relevant scientific discipline with minimum experience of 10 years within quality control.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Volunteer time to participate within your community
• Vacation, sick time and holidays
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Adoption and family-planning benefits
• Highly competitive and inclusive medical, dental and vision coverage options
• Paid sabbatical after 5 years; every 3 years thereafter
• Free premium access to fitness, nutrition, and mindfulness classes
• Location-specific perks and extras!
• Exclusive preferred pricing on Peloton fitness equipment
• Discretionary year-end shutdown
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Free parking or subsidized commuter passes
• 401k match and Financial Planning tools

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 [email protected]. (EEO/AAP Employer)

]]>