Manager, Audits & Inspections - Quality Systems & Compliance
Core
Lead quality oversight for client audits and regulatory inspections, ensuring compliance with FDA, EMA, and ISO standards in the pharmaceutical/medical device sector.
Role type
Senior IC manager (Quality Systems & Compliance)
Builds
Inspection readiness and compliance programs for regulatory agencies and clients
Domain
Pharmaceutical/Medical Device Quality Assurance
Required skills
Regulatory compliance (21 CFR, ISO, ICH), Audit & Inspection management, CAPA management, Electronic Quality Management Systems (Documentum, Veeva Vault, TrackWise), Cross-functional coordination, People leadership
Preferred skills
None stated
Technologies
Documentum, Veeva Vault, TrackWise
Responsibilities
Oversee scheduling and execution of external client audits; Plan and execute mock and actual regulatory inspections; Manage documentation and record retention for compliance; Coordinate CAPA implementation and effectiveness checks; Lead, mentor, and coach direct reports on quality matters
Seniority
Manager, direct reports
