Director, QC
Core
Strategic and operational leadership for the Quality Control Department supporting GMP manufacturing, release testing, stability programs, and regulatory compliance in a multi-client CDMO environment.
Role type
Director, Quality Control (GMP Manufacturing)
Builds
GMP-compliant pharmaceutical products and quality systems for biopharma clients
Domain
Biopharma / Contract Development and Manufacturing Organization (CDMO)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations expertise, laboratory electronic systems management, strategic planning, budget management, cross-functional leadership, data analysis, problem-solving, team development, regulatory compliance, operational excellence
Preferred skills
MS or PhD in Life Sciences/Engineering, multi-client CDMO experience, JMP/statistical software proficiency, corporate method development
Technologies
LIMS, CDS, SDMS, ELN, JMP
Responsibilities
Lead strategic direction for QC department including method transfer and release testing; oversee laboratory infrastructure and electronic systems; manage departmental budget and headcount; drive continuous improvement and quality culture; serve as client-facing SME for analytical technologies; lead investigations and audit responses; develop organizational strategies and KPIs
Seniority
Director, strategic leadership with hands-on operational oversight
