Senior Manager, Clinical QA & GxP Compliance
Skills
- Strong knowledge of global GCPs including U.S. FDA, EU, and ICH regulations
- Excellent written and verbal communication skills
- Ability to manage shifting priorities flexibly
- Motivated, committed, and self-managed
- Proficient in GxP audit execution and clinical quality assurance
Responsibilities
- Plan, conduct, manage, and report results of GxP audits including internal processes, clinical sites, vendors, CSRs, and TMFs
- Train and coach Clinical QA personnel and contract service providers on GxP audits
- Support inspection readiness and Health Authority Inspections, including War Room leadership
- Identify GxP inspection risks and lead mitigation activities through cross-functional teams
- Develop and deliver inspection training for SMEs and support teams
- Review GCP-associated controlled documents to ensure compliance with regulatory requirements
- Guide internal departments and clinical teams on GCP compliance issues and corrective actions
- Ensure timely completion and closure of deviations and CAPAs with proper evaluation
- Support quality oversight activities as assigned by Clinical QA and Executive Management
Education
- Bachelor's Degree in scientific or related technical discipline required
Benefits
- Generous vacation time and public holidays
- Volunteer days
- Long-term incentives and employee stock purchase plans
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
- Professional development plans
Average salary estimate
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