Senior Manager, Investigations bei Moderna

The Role

The Senior Manager, Manufacturing Investigations will provide strategic and operational leadership for the investigations function at the Marlborough manufacturing site. This individual will lead a team of Specialists and Sr. Specialists responsible for managing deviations and CAPAs across DNA, mRNA, LNP, Drug Product (DP), Buffer Preparation, Warehouse Operations, QC operations and Facilities/Utilities.

This role is critical to ensuring investigation quality, driving timely and effective resolution of issues, and sustaining inspection readiness across all manufacturing areas. The Senior Manager will report into the Site Sr. Director, INT Operations, and will partner closely with cross-functional stakeholders including QA, QC, MSAT, Digital, Facilities, and Supply Chain to build a culture of accountability, quality, and operational excellence.

Here’s What You’ll Do

• Provide direct leadership and people management for the site Investigations team, including coaching, development, and performance management.

• Own the investigation program for the Marlborough site, ensuring robust, compliant, and inspection-ready processes for deviations, non-conformances, and CAPAs.

• Lead strategy and execution for complex investigations involving multiple technologies and functional areas (DNA, RNA, LNP, DP, Buffer Prep, QC, Warehouse, Facilities).

• Partner with Quality and Manufacturing leadership to ensure timely root cause analysis and implementation of effective CAPAs.

• Serve as site lead during audits/inspections for deviation and CAPA topics; coach team members and SMEs for success in regulatory engagements.

• Accountable for reporting of site deviation metrics at Monthly Business Review and Executive updates.

• Identify, analyze, and trend investigation metrics; develop and execute initiatives to reduce deviation recurrence and improve system effectiveness.

• Represent Marlborough in network forums, driving harmonization of investigation practices across sites.

• Collaborate on continuous improvement efforts, digital solutions, and lean initiatives related to investigation workflows and quality systems.

• Support startup and tech transfer activities by embedding investigation best practices into new processes and systems.

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

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.

• 10+ years of experience in biopharmaceutical operations, with significant focus on manufacturing investigations, quality systems, or GMP compliance.

• Strong knowledge of deviation and CAPA systems, root cause analysis tools (e.g., 5 Whys, Fishbone, Kepner-Tregoe), and regulatory expectations (FDA, EMA, etc.).

• Experience preparing for and participating in regulatory inspections as a subject matter expert or functional lead.

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

• Excellent communication, leadership, and cross-functional collaboration skills.

• Proven experience leading high-performing technical teams in a regulated environment.

• Comfort with data analysis, KPI management, and continuous improvement.

• Familiarity with electronic quality systems (e.g., Veeva, TrackWise) and digital batch record systems preferred.

• Lean/operational excellence mindset and a strong sense of urgency in driving issues to resolution.

• 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 US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• 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. 

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. 

Our Working Model 

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. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Equal Opportunities

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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

Accommodations

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 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 [email protected]. 

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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