Operation Quality Section Head
Core
Supervise Operational Quality (OQ) activities, batch release, and quality systems to ensure GMP compliance and operational oversight across manufacturing value streams.
Role type
Senior Operational Quality Section Head
Builds
Manufactured pharmaceutical batches and compliant quality systems
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP compliance, Quality Assurance, Batch release management, Deviation investigation, CAPA management, Risk assessment, Team leadership, Regulatory knowledge (GxP/EDA), Data integrity, Technical writing
Preferred skills
Budgetary control, Cross-functional partnership, Continuous improvement, Digital fluency, Lean Management
Technologies
SAP, ERP systems
Responsibilities
Supervise OQ Officers and execute routine oversight activities; Lead deviations, OOS/OOT investigations, and CAPAs; Oversee and perform batch release activities and Authorized Person duties; Drive quality performance improvement via KPIs and QIPs; Lead, coach, and develop direct reports.
Seniority
Senior, hands-on IC with people management