Audit Program Manager - Quality Assurance
Core
Responsible for regulatory compliance activities related to the Internal Audit Program, conducting audits internally and at suppliers/contractors to ensure adherence to regulatory standards and Quality System requirements.
Role type
Audit Program Manager (Quality Assurance)
Builds
Internal audit programs and supplier audits for regulatory compliance
Domain
Life Sciences (Pharmaceuticals/Medical Devices) + Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Internal audit execution, risk identification, CAPA development, regulatory gap analysis, cross-functional project coordination, global regulatory updates
Preferred skills
Auditor certification, IVD sector knowledge
Technologies
GMP, ISO 13485, 21 CFR 820/600, IVDD
Responsibilities
Plan and execute internal audits at production sites and commercial affiliates across Europe, identify compliance risks and support improvement plan implementation, draft annual audit plans and report results, lead initiatives to close regulatory gaps including CAPA development, support Inspection Readiness activities, participate as an expert during audits, coordinate cross-functional projects and promote change management, continuously update knowledge on global regulations
Seniority
Mid-Senior, hands-on IC