Associate Director, QC Analytics
Core
Provide operational leadership for routine GMP analytical testing, leading a team of managers responsible for seven-day laboratory operations to ensure predictable product release and in-process testing execution.
Role type
Senior IC Associate Director, QC Operations
Builds
Routine GMP testing workflows for advanced therapies (biologics, cell/gene therapy)
Domain
Biotechnology / Pharmaceutical Manufacturing / Quality Control
Required skills
GMP laboratory operations, team leadership, capacity planning, cGMP compliance, data integrity, method execution, laboratory investigations, stakeholder management
Preferred skills
Advanced degree in life sciences, experience with analytical technologies (flow cytometry, chromatography), LIMS/QMS systems, interface with analytical lifecycle teams
Technologies
LIMS, CDS, ELN, SDMS, QMS, CMMS, ERP
Responsibilities
Own integrated plan for routine release and in-process GMP testing; lead safe, compliant, inspection-ready laboratory operations; partner with QCAT on method transfer and operational readiness; lead response to deviations, OOS results, and CAPAs; develop and manage a team of managers for seven-day operations
Seniority
Senior, hands-on IC with people leadership