Principal Quality Compliance Specialist, Inspection (CVRM)
Core
Lead site inspection readiness and self-inspection programs for a greenfield aseptic drug product manufacturing facility.
Role type
Principal Quality Compliance Specialist (Site Inspection Lead)
Builds
A state-of-the-art facility for next-generation metabolic medicines (obesity, Type 2 diabetes)
Domain
Pharmaceutical manufacturing (aseptic, sterile) and regulatory compliance
Required skills
GxP regulations expertise, site inspection program leadership, root-cause analysis, cross-functional coaching, regulatory interaction management
Preferred skills
Advanced degree, experience in digital/sterile manufacturing environments
Technologies
GxP regulations (FDA, EMA, ICH, ISO), digital tools, real-time data analytics
Responsibilities
Lead self-inspection and internal audit strategy; develop and execute inspection readiness plans; manage Health Authority commitments and post-inspection actions; support quality systems including recalls and supplier management
Seniority
Principal, hands-on IC with strategic oversight
