Join us in changing lives by working as a Senior Manager, Quality Assurance in Durham, NC. This role drives Quality Operations excellence across a multi-client GMP environment, overseeing manufacturing quality, batch disposition, and quality systems. The role is part of advancing our mission to enable life-changing therapies to reach patients around the world.
Requirements
- Bachelorās degree 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.
Benefits
- Competitive total reward packages
- Wellbeing programs that support your mental and physical health
- Career development opportunities to help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities