Senior Auditor, Supplier Audit & Compliance
Core
Conduct comprehensive quality system audits of third-party service providers and manufacturers to ensure compliance with global regulatory requirements for pharmaceuticals and medical devices.
Role type
Senior IC Quality Auditor (Supplier Audit & Compliance)
Builds
Approved supplier lists, global audit schedules, and regulatory compliance for new product development programs.
Domain
Pharmaceutical and Medical Device Manufacturing
Required skills
GxP regulations interpretation, external supplier audit planning, corrective action review, supplier management processes, regulatory agency audit collaboration, departmental system maintenance, cross-functional leadership, strategic compliance initiatives.
Preferred skills
Quality Assurance auditing, Pharmaceutical/Device Manufacturing experience, ASQ CQM/CQA accreditation.
Technologies
GMP, MDR, IVDR, US FDA regulations, EU regulations
Responsibilities
Plan and conduct external supplier audits, provide training on GxP regulations, maintain approved supplier lists, collaborate on regulatory agency audits, develop departmental procedures, lead cross-functional projects.
Seniority
Senior, hands-on IC with mentorship