QA Manager, Audit and Inspection Managment
Core
Planning, execution, and management of GxP audit and regulatory inspection readiness programs for late-stage pharmaceutical development.
Role type
Senior individual-contributor QA Manager (Audit & Inspection)
Builds
Sustainable inspection-readiness programs and compliant quality systems for Phase 3 clinical development toward regulatory submission.
Domain
Pharmaceutical/Biotechnology / Regulatory Compliance (GxP)
Deliverable
client delivery
Required skills
GxP audit planning and execution, FDA/health authority inspection support, CAPA management, risk-based vendor oversight, regulatory interpretation, technical writing, root-cause analysis
Preferred skills
Phase 3 development experience, BIMO/PAI support, cross-functional auditing (GCP/GMP/GLP/GVP), outsourced CRO/CDMO models, Lead Auditor certification
Technologies
GxP frameworks, FDA regulations, ICH guidance
Responsibilities
Develop and maintain risk-based annual GxP audit programs; Conduct internal, external, and vendor audits; Support FDA and health authority inspections; Manage inspection readiness assessments and mock inspections; Track audit findings and CAPA effectiveness; Coordinate logistics and responses during regulatory inspections.
Seniority
Senior, hands-on IC
