Deviation Investigation Team Manager
Core
Manage and lead a team of Technical Investigators to oversee complex manufacturing and technical-service deviation investigations, ensuring root cause analysis, product impact assessments, and CAPA implementation for biopharmaceutical products.
Role type
Senior IC Deviation Investigation Team Manager
Builds
Deviation investigation reports, root cause analyses, CAPAs, and batch disposition decisions
Domain
Biopharmaceutical manufacturing / GMP quality systems
Required skills
Deviation investigation management, Root cause analysis (RCA), Risk management (FMEA), GMP compliance, Technical writing, Stakeholder management, Customer communication, Continuous improvement, Data-driven decision making
Preferred skills
Regulatory inspection support, Cross-functional collaboration, Strategic decision making
Technologies
FMEA, GMP quality systems
Responsibilities
Lead and develop the Deviation Investigation Team; Oversee timely closure of manufacturing and technical-service deviations; Apply risk-based approach to quality events; Partner with cross-functional stakeholders (Manufacturing, QA, QC, QP); Lead customer communications relating to deviation events; Drive continuous improvement initiatives; Monitor and report investigation performance metrics
Seniority
Senior, hands-on IC