Senior Manager/Associate Director, QA Operations
Core
Lead Quality oversight for biological Drug Substance clinical manufacturing, warehousing, and distribution operations to ensure regulatory compliance and operational excellence.
Role type
Senior Manager/Associate Director, QA Operations
Builds
Compliant clinical supply chain for antibody-based medicines
Domain
Biotechnology / Pharmaceutical Manufacturing (cGMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP regulatory expertise, biological Drug Substance manufacturing knowledge, aseptic process oversight, root cause analysis, CAPA management, change control, audit readiness, team leadership, ERP/eQMS/LIMS proficiency
Preferred skills
None stated
Technologies
SAP, eQMS, LIMS
Responsibilities
Own Quality oversight across GMP manufacturing, warehousing, and distribution; drive batch record review and material disposition; lead root cause investigations, CAPAs, and change controls; provide Quality partnership for tech transfers and new product introductions; oversee material qualification and release; champion continuous improvement initiatives; shape Quality policies and procedures; maintain inspection readiness; lead risk-based evaluation and mitigation; build and coach a high-performing QA Operations team.
Seniority
Senior Manager/Associate Director, hands-on leadership
