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gcp audits veeva qms sops📋 Description
- Lead PV-GCP QA support for clinical programs.
- Facilitate PV/GCP audits and audit programs.
- Implement QA activities ensuring regulatory compliance.
- Identify process improvements to prevent quality issues.
- Track QA metrics and vendor quality issues.
- Lead PV inspection readiness and regulatory responses.
🎯 Requirements
- BA/BS degree required; advanced degree preferred.
- 6+ yrs (Sr Manager) or 8+ yrs (AD) in biopharma R&D with PV/GCP QA experience.
- Min 2 yrs leading teams/projects.
- Experience drafting, reviewing SOPs.
- Knowledge of Global GVP and GCP regs; validated computerized systems.
- Experience conducting audits and health authority inspections.
- Knowledge of Veeva or similar QMS; inspection management tools a plus.
🎁 Benefits
- Base range $170,000-$206,000/year.
- Benefits package, equity, and annual target bonus.
- 401K with employer contributions.
- Generous stock options and ESPP.
- 20 days PTO and 18 holidays to start.
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