Senior Manager, Quality Assurance

oxfordbiom•Durham, NC

1d•Onsite

About The Position

This senior leadership role drives Quality Operations excellence across a multi-client GMP environment. You’ll oversee manufacturing quality, batch disposition, and quality systems, while acting as a key interface between teams and clients to ensure compliant, inspection-ready operations. Supporting the growth of a new CGT CDMO facility, you’ll partner cross-functionally to build scalable quality systems and enable operational readiness. playing a key part in advancing our mission and making a real difference.

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.
External applicants must be eligible to work in the United States.

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.
Support client audits and regulatory inspections, including preparation, hosting, and responses.
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.