Manager, Quality Assurance

Description

• Provide strategic and operational quality oversight to QC laboratories at Harwell, aligned with Moderna’s global quality framework.
• Ensure QC methods, processes, and SOPs are scientifically robust, validated, and aligned with regulatory expectations (e.g., ICH Q2 (R2), USP/Ph. Eur.).
• Lead the QA review and approval of laboratory-related documentation, such as SOPs, analytical reports, Annual Product Quality Reviews, and trend analyses.
• Oversee qualification, validation, and transfer of analytical methods to internal and external labs, ensuring lifecycle management and scientific integrity.
• Support continuous GMP compliance by ensuring adherence to Good Documentation Practices and Data Integrity standards.
• Oversee and support OOS/OOT investigations to ensure they are prompt, unbiased, scientifically justified, and concluded with effective CAPAs.
• Conduct on-the-floor QA oversight via lab walkthroughs, data reviews, and staff coaching.

Qualifications

• Education: Bachelor’s Degree in a scientific field.
• Experience: 8 – 10+ years of Biopharmaceutical / Pharmaceutical Industry within Quality.
• As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.

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

• Strong working knowledge of cGMP regulations, ISO standards, and other relevant regulatory guidance document.
• Experience with regulatory inspections as a Subject Matter Expert (SME), including direct interactions with worldwide health authorities.
• Demonstrated experience in analytical or microbiological method validation.
• Experience with OOS/OOT investigation management, risk management, and digital quality systems.
• Strong leadership skills with ability to develop, mentor, and motivate diverse teams.
• Excellent project management, organizational, and communication skills.
• Experience interacting with regulatory authorities during regulatory inspections.
• Demonstrated ability making risk-based decisions.