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gcp audits ich qms capa📋 Description
- Lead GCP QA programs to ensure FDA/EMA/ICH compliance
- Provide ICH/GCP guidance across the clinical development life cycle
- Plan and conduct GCP audits of vendors, sites, TMF
- Manage QMS, SOPs, training, and CAPAs
- Provide cross-functional compliance guidance and strategic advice
- Lead and develop Clinical QA staff and support quality initiatives
🎯 Requirements
- 10+ years in GCP QA within CRO/biotech/pharma
- Bachelor's degree in life sciences; advanced degree preferred
- Experience leading GCP audits across sites, TMF, and vendor qualification
- Strong knowledge of FDA, EMA, and ICH regulations and global GCP
- Experience supporting regulatory inspections and inspection readiness
- Translate regulatory requirements into effective quality systems and risk-based processes
🎁 Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life and disability insurance
- Parental leave
- Paid time off for sick leave and vacation
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