Associate Director QA, GMP External Operations
Core
Provide end-to-end QA oversight of external manufacturing operations across CDMOs, from process development and technology transfer through routine clinical and commercial execution.
Role type
Senior IC quality assurance director (external manufacturing)
Builds
compliant and reliable supply of cell & gene therapy/biologics products
Domain
Biotechnology / Cell & Gene Therapy / Biologics
Required skills
global GMP regulatory requirements, QA operations, external manufacturing oversight, technology transfer, risk management, root cause analysis, strategic planning, data analytics
Preferred skills
autologous cell therapy QA, aseptic manufacturing, analytical testing, fill/finish
Technologies
GMP systems, digitization tools
Responsibilities
Establish QA oversight model and governance, ensure compliance with GMP and regulatory requirements, monitor CDMO quality performance, lead deviations and CAPAs, maintain audit readiness
Seniority
Senior, management/supervisory