Senior Manager, Deviation Management – Quality Assurance
Core
Own deviation management governance to ensure deviations are triaged, investigated, and closed in a timely, compliant, and high-quality manner for a biopharmaceutical company.
Role type
Senior Manager, Quality Assurance (Deviation Management)
Builds
Inspection-ready deviation records, process narratives, and management review packs for audits and inspections.
Domain
Biopharmaceutical / GMP Quality Management Systems
Deliverable
dashboards & analysis
Required skills
Deviation governance, root cause analysis (RCA) facilitation, CAPA linkage, effectiveness verification, trend analysis, cross-functional leadership, inspection readiness documentation, Veeva Vault Quality proficiency
Preferred skills
Pharmaceutical/biotech external manufacturing network governance, eQMS workflow management, continuous improvement facilitation
Responsibilities
Establish standards for investigation rigor and root cause analysis; drive performance management of deviation backlogs; coach teams on investigation quality; maintain inspection-ready documentation; produce governance playbooks and KPI dashboards
Seniority
Senior, hands-on IC with team leadership