Director of Quality Control
Core
Leads all QC operations within a pharmaceutical manufacturing facility, ensuring reliable, compliant testing that meets regulatory expectations and supports timely product release.
Role type
Director of Quality Control (Leadership)
Builds
Sterile pharmaceutical products (vials, pre-filled syringes, IV bags)
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
cGMP compliance, FDA/EMA inspection readiness, laboratory operations management, data integrity (ALCOA+), method validation, stability program management, OOS investigation, team leadership, change control, CAPA management
Preferred skills
Master's or PhD in Chemistry/Biochemistry/Microbiology, 10+ years QC experience, 5+ years leadership in GMP lab, experience with LIMS/ELN, Lean lab practices
Technologies
LIMS, ELN, analytical instrumentation
Responsibilities
Provide strategic leadership for QC teams (chemistry, microbiology, stability, raw materials); Direct day-to-day QC operations to support manufacturing schedules; Ensure compliance with cGMP, FDA/EMA/ICH guidelines, and USP standards; Oversee method validation, verification, and lifecycle management; Manage stability studies and trend analysis; Drive continuous improvement initiatives (automation, digitalization); Lead cross-functional collaboration on regulatory submissions and vendor qualification.
Seniority
Director, strategic leadership & operations management