Senior Manager, Investigations

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 d