Senior Director, Quality Control
Core
Leads all Quality Control operations at a biopharmaceutical manufacturing site, ensuring safe, compliant, and predictable execution of product release, in-process testing, and environmental monitoring.
Role type
Senior Director, Quality Control (Leadership)
Builds
Advanced therapies (biologics, cell/gene therapy) via compliant manufacturing processes
Domain
Biopharmaceuticals / Regulated Manufacturing
Required skills
GMP laboratory controls, analytical testing, microbiology, environmental monitoring, raw material disposition, stability testing, data integrity, inspection readiness, seven-day operations management, strategic planning, financial stewardship, organizational design, talent development, investigation management, CAPA management, client governance, regulatory compliance
Preferred skills
Lean Six Sigma, Lean Lab, Digital Lab practices, multi-program or CDMO environment experience
Technologies
Laboratory Information Management Systems (LIMS), analytical equipment, digital QC tools
Responsibilities
Lead integrated QC organization and operating model; ensure safe and compliant execution of product release and in-process testing; partner with Manufacturing on STAT in-process samples; oversee analytical lifecycle and method validation; manage laboratory events, deviations, and investigations; represent QC in client audits and regulatory inspections; develop technical leaders and align resources with demand.
Seniority
Senior Director, strategic leadership & operational oversight