Senior Manager, Corporate Quality – R&D Audits

The Sr. Manager, Corporate Quality Audits provides GxP oversight for the vendor management and audit program, with primary responsibility for GPV and GLP/GCLP vendor audits. Ensures compliance with FDA, ICH, OECD, and other global requirements; supports integration of acquired programs; drives continuous improvement of quality systems.

Primary Responsibilities:
- Conduct GPV and GLP/GCLP external audits of approved vendors; develop audit plans; prepare reports; communicate/escalate findings including compliance risk.
- Conduct quality audits for qualification of new vendors.
- Conduct for-cause audits of external vendors as requested.
- Review/evaluate vendor audit responses against current industry standards to ensure sufficient quality controls.
- Serve as QA point of contact for vendor-related audits, performance oversight, and compliance decisions.
- Assist in maintaining annual external audit schedules.
- Provide support during GXP health authority inspections.
- Revise/create GxP quality documentation (SOPs, policies, templates, work instructions).
- Manage auditing files/records/reports and related vendor licenses/certificates.
- Perform other assigned duties.

Education and Requirements:
- Bachelor’s degree in Life Sciences; 8+ years in pharmaceutical/biotech drug development (Advanced degree preferred).
- Minimum 5 years in GPV and/or GLP/GCLP with external and internal auditing.
- Extensive experience with OECD GLP/GPV principles, ICH E6 GCP, FDA regulations, and EU requirements.
- Excellent interpersonal skills and ability to build relationships cross-functionally.
- Travel up to 20%.

Application Instructions:
- Candidates must be authorized to work in the U.S.