Senior Quality Control Manager
Core
Own quality control across GMP and non-GMP environments from R&D through commercial manufacturing, leading a team of analysts and serving as the primary interface with external partners.
Role type
Senior Quality Control Manager
Builds
QC systems, processes, and lab operations infrastructure for pharmaceutical ingredient manufacturing
Domain
Pharmaceutical manufacturing / Biosynthesis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, team leadership, method development and validation, OOS/OOT investigation, CAPA implementation, regulatory strategy, data integrity management, chromatographic analysis, spectroscopic analysis, wet chemistry techniques
Preferred skills
Bioanalytical techniques, audit experience, vendor selection and lab qualification
Technologies
LIMS, Empower, ELNs
Responsibilities
Lead and develop a team of QC Analysts and Specialists; Build and improve lab operations infrastructure; Ensure compliance with GMP, ICH, USP/EP, and FDA/EMA standards; Serve as the primary QC point of contact for CDMOs, CROs, and contract testing labs; Lead method development, transfer, and validation; Own complex investigations (OOS, OOT) through root cause analysis and CAPA
Seniority
Senior, hands-on IC with leadership responsibilities
