Director, Quality Control - Raw Materials
Core
Lead the Quality Control department for raw materials, overseeing incoming inspection, testing, release, and qualification programs to support gene therapy development and manufacturing.
Role type
Director, Quality Control (Raw Materials)
Builds
Qualified raw material supply chain for pre-clinical, clinical, and commercial gene therapy manufacturing
Domain
Biotechnology / Gene Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, raw material testing program management, material qualification, regulatory compliance (cGMP, USP/EP/JP/BP), analytical method expertise, budgeting, CAPEX procurement, OOS/OOT investigation, deviation/CAPA/change control management, GMP laboratory readiness
Preferred skills
Scaling QC laboratories, analytical instrumentation troubleshooting, regulatory agency interactions, supplier quality management, data integrity systems
Technologies
HPLC, ELISA, SDS-PAGE, mass spectrometry, qPCR, cell-based assays
Responsibilities
Manage raw material sample receipt, incoming inspection, testing, and release; Develop and implement material qualification programs; Author and review QC reports, SOPs, and protocols; Lead OOS/OOT investigations, deviations, CAPAs, and change controls; Oversee analytical equipment qualification and engineering efforts; Ensure adherence to global pharmacopeias and regulatory requirements
Seniority
Director, strategic leadership & department management
