Quality Control Lead (Sterile Product Manufacturing)
Core
Lead Quality Control operations for sterile product manufacturing, ensuring compliance with EU GMP, FDA, and global regulatory standards across incoming inspection, raw material, in-process, environmental monitoring, and finished product testing.
Role type
Senior Management Quality Control Lead (Sterile Manufacturing)
Builds
Compliant QC operations, validated analytical methods, and a high-performing QC organization for sterile pharmaceutical/biotech products.
Domain
Pharmaceutical/Biotech Manufacturing (Sterile Products)
Required skills
GMP compliance, pharmaceutical/biotech analytical environment experience, personnel management, project management, microbiological analysis, analytical method transfer and validation
Preferred skills
Start-up experience, complex biologic method experience, advanced degree, Qualified Person (QP) eligibility, budget management
Technologies
Laboratory equipment qualification, environmental monitoring systems, GMP documentation systems
Responsibilities
Oversee incoming inspection, raw material, in-process, environmental monitoring, and finished product testing; Lead establishment and continuous improvement of QC laboratories; Build and develop the QC organization; Author, review, and approve complex GMP documentation; Manage department budget and generate QC needs assessments; Maintain oversight of outsourced activities.
Seniority
Senior, Management