Director, QC & Microbiology
Core
Strategic and operational leadership for Quality Control Chemistry and Microbiology functions, ensuring scientific excellence, regulatory compliance, and laboratory capacity for biopharma operations.
Role type
Director, QC & Microbiology (Strategic IC)
Builds
QC and Microbiology laboratory operations, testing capabilities, and organizational capability
Domain
Biopharma / CDMO / GMP-regulated laboratory
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (laboratory systems, testing capabilities)
Required skills
Strategic leadership, GMP compliance, laboratory capacity planning, budget management, regulatory inspection readiness, people leadership, data integrity oversight, laboratory modernization, risk management
Preferred skills
MS or PhD in life sciences, sterile/biologic/parenteral experience, multi-client CDMO operations, contract laboratory governance
Technologies
LIMS, CDS, SDMS
Responsibilities
Establish and execute QC/Microbiology strategy; oversee raw material, in-process, release, stability, and environmental testing; maintain inspection readiness and GMP compliance; lead laboratory modernization and automation; build and develop high-performing technical teams; partner with cross-functional teams on site objectives
Seniority
Director, strategic leadership & people management
