Senior Manager, Quality Assurance

Responsibilities

• Lead and develop a high-performing Quality Operations team supporting GMP manufacturing, batch disposition, and quality systems within a multi-client CDMO environment.
• Provide strategic and operational oversight of QA activities across Manufacturing, Warehouse, QC, Supply Chain, and Facilities to ensure inspection readiness and compliance.
• Oversee QA floor support for GMP manufacturing operations, including batch record review, QA holds, and operational walkthroughs.
• Execute and support batch disposition decisions aligned with client agreements, regulatory requirements, and product specifications.
• Lead and approve quality system activities including deviations, investigations, CAPAs, change controls, and master batch records.
• Act as the primary Quality Operations interface for assigned clients, managing Q2Q interactions, communications, and audits.
• Partner cross-functionally with Manufacturing, MSAT, QC, Engineering, and Supply Chain to support tech transfer, validation, and program delivery.
• Ensure effective quality oversight of facility operations, environmental monitoring, and contamination control programs.
• Drive continuous improvement initiatives to enhance right-first-time performance, reduce deviations, and improve operational efficiency.

Requirements

• Bachelor’s degree (or higher) in Life Sciences, Chemistry, Biology, Biochemistry, Engineering, or a related discipline.
• 8+ years of experience in GMP-regulated pharmaceutical or biotechnology environments.
• 4+ years of leadership experience managing QA or Quality Operations teams.
• Strong expertise in Quality Assurance supporting GMP manufacturing, including batch review and disposition.
• Experience in cell and gene therapy, viral vectors, or advanced biologics manufacturing environments.
• Proven experience in CDMO or multi-client environments with client-facing quality responsibilities.
• Strong knowledge of GMP processes, aseptic manufacturing, environmental monitoring, and contamination control.
• Demonstrated ability to build and lead high-performing teams and foster a strong quality culture.
• Excellent communication, stakeholder management, and problem-solving skills, with a risk-based decision-making approach.