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 Compliance (GxP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GPV and GLP/GCLP auditing, FDA regulations, ICH E6 GCP, OECD Principles, EU Requirements, SOP creation, audit planning, risk escalation
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 qualification audits for new vendors, perform for-cause audits, review vendor audit responses, 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, manage auditing files and records
Seniority
Senior Manager, hands-on IC with strategic oversight
