Deputy Director of DS Manufacturing Quality Systems
Core
Lead and develop a Quality Systems organization responsible for the full lifecycle of manufacturing quality records, including deviation investigations, CAPAs, effectiveness checks, and QMS document updates.
Role type
Senior leadership Quality Systems Manager (Drug Substance Manufacturing)
Builds
Manufacturing quality records and compliance frameworks
Domain
Biopharmaceutical manufacturing / Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, deviation investigation leadership, CAPA management, cross-functional stakeholder consensus building, audit and inspection defense, team coaching and development, risk-based decision making, regulatory communication
Preferred skills
Direct report management experience, process improvement initiative leadership
Technologies
QMS documentation systems, regulatory reporting tools
Responsibilities
Lead and develop an agile Quality Systems team; Own on-time closure of deviation investigations, CAPAs, and periodic reviews; Review quality records for completeness and conduct management-level reviews; Oversee timely and accurate QMS document updates; Coach and develop the Quality Systems team; Lead cross-functional engagement with Manufacturing, QC, and QA; Serve as site representative during audits and regulatory inspections; Champion continuous improvement initiatives to reduce deviations and improve cycle time.
Seniority
Senior, hands-on IC with leadership responsibilities
