OQ Team Lead (Quality Oversight)
Core
Lead a small Operational Quality team to provide quality oversight across manufacturing sites, ensuring product quality and patient safety through GMP compliance and risk management.
Role type
Senior Operational Quality Team Lead
Builds
Quality oversight systems and compliance across manufacturing operations
Domain
Biopharmaceutical manufacturing / Quality Management Systems
Required skills
Quality Management Systems (QMS), GMP compliance, Root Cause Analysis, CAPA management, Data trending, Statistical analysis, Batch record review, Audit support, Risk assessment, Cross-functional collaboration
Preferred skills
Team leadership, Inspection readiness, US regulatory expectations
Technologies
None explicitly stated
Responsibilities
Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System; Oversee investigations of deviations, non-conformances, and complaint-related issues; Support product introductions, transfers, and changes; Provide oversight and scheduling of quality oversight activities; Maintain presence as first line of contact for initial quality issue management; Perform spot-checks across GMP areas including production, testing, QC, warehouse, facilities, and utilities; Collaborate on corrective and preventive actions (CAPAs); Review GMP documentation ensuring Good Documentation Practice (GDP); Track and trend quality oversight observations; Participate in site-based audits as SME for Quality Oversight.
Seniority
Senior, hands-on IC with leadership responsibilities