Senior Manager, Corporate Quality – R&D Audits
Core
Provides GxP oversight for the vendor management and audit program, ensuring compliance with FDA, ICH, OECD, and other global requirements for pharmaceutical/biotech vendors.
Role type
Senior Manager, Corporate Quality Audits
Builds
Vendor audit programs and quality systems for drug development
Domain
Pharmaceutical/Biotech, Regulatory Quality
Required skills
GxP oversight, GPV/GLP/GCLP auditing, FDA/ICH/OECD regulations, vendor qualification, audit planning, report writing, SOP creation, cross-functional collaboration
Preferred skills
Advanced degree in Life Sciences, experience with acquired program integration
Technologies
GxP documentation systems, audit management tools
Responsibilities
Conduct GPV and GLP/GCLP external audits of approved vendors; Conduct quality audits for new vendor qualification; Perform for-cause audits; Review vendor audit responses against industry standards; Serve as QA point of contact for vendor audits; Maintain annual external audit schedules; Support GxP health authority inspections; Create and revise GxP quality documentation (SOPs, policies, templates); Manage auditing files, records, and licenses.
Seniority
Senior Manager, hands-on IC with strategic oversight
