Quality Manager
Core
Lead Quality Assurance and Quality Control operations for the PeproGMP recombinant protein product portfolio, ensuring GMP compliance and continuous improvement in a life sciences manufacturing environment.
Role type
Senior Quality Manager (Life Sciences Manufacturing)
Builds
GMP-compliant recombinant protein products (cytokines, growth factors, antibodies, ELISA kits) for academic, government, biotech, and pharmaceutical customers.
Domain
Life Sciences / Biotechnology / Regulated Manufacturing
Required skills
GMP compliance, Quality Management Systems (QMS), ISO 9001, CAPA management, root cause analysis, laboratory operations leadership, risk-based decision making, audit readiness, data integrity, stakeholder collaboration
Preferred skills
Advanced degree in science/technical/business, experience with 21 CFR Part 11/820/QMSR, ICH guidelines (Q9, Q10), Practical Process Improvement (PPI)
Technologies
GMP systems, ISO 9001 frameworks, electronic records/signatures (21 CFR Part 11), analytical testing equipment
Responsibilities
Lead and develop the Quality Control team; oversee Quality Management System and ISO 9001 certification; manage quality records (deviations, CAPAs, change controls); partner with cross-functional teams to resolve product/process issues; support customer audits and inquiries; drive continuous improvement initiatives.
Seniority
Senior, hands-on IC with people leadership