Associate Manager-Quality Investigation
Core
Review and challenge microbiological deviations, OOS/OOT, contamination, and sterility assurance investigations to ensure scientific robustness and regulatory compliance.
Role type
Senior IC quality investigation manager (microbiology)
Builds
Investigation reports, root cause analyses, and CAPAs for sterile pharmaceutical products
Domain
Pharmaceutical manufacturing (sterile) + Quality Assurance
Required skills
Microbiological investigations, Root cause analysis, Risk management, Data integrity, Regulatory compliance (FDA/EMA/MHRA), Technical report review
Preferred skills
CAPA effectiveness, Contamination control strategies, Aseptic processing knowledge, Coaching and mentoring, Continuous improvement
Technologies
5-Why, Fishbone Analysis, Fault Tree Analysis, Human Error Reduction techniques
Responsibilities
Independently review and challenge microbiological deviation investigations; Evaluate investigation strategy and data integrity; Drive effective root cause analysis using structured tools; Assess product and compliance risks; Review and challenge proposed CAPAs; Partner with cross-functional teams to strengthen investigation effectiveness; Coach investigation owners on scientific reasoning and best practices; Identify recurring trends and systemic gaps.
Seniority
Senior, hands-on IC