Senior Manager, Clinical Quality Audit & Inspection Program
Skills
- Strong knowledge and application of GCP, GPvP, and GCLP
- Proven experience in inspection readiness and supporting regulatory inspections (FDA, EMA)
- Ability to plan and execute risk-based audits of vendors and investigator sites
- Experience managing CAPAs and audit records in Veeva QMS or similar QMS
- Excellent audit report writing, presentation, and defense of findings
- Ability to travel up to 40%–60% and work independently
- Strong leadership, cross-functional partnering, and continuous improvement skills
Responsibilities
- Develop SOPs, work instructions, templates, and forms for a fit-for-purpose clinical audit and inspection program
- Create and execute dynamic, risk-based audit strategies and plans for sponsor processes, systems, trials, sites, and vendors/CSPs
- Plan, lead, conduct, document, report, and follow up on clinical quality audits per regional regulations and quality agreements
- Manage audit findings and CAPAs in Veeva QMS; review and approve responses and corrective actions
- Ensure timely escalation of critical findings and support remediation activities
- Develop and monitor timeliness and trend metrics for audit findings/CAPAs and present improvement plans to senior management
- Provide education and guidance on audit processes and inspection readiness
- Partner with cross-functional stakeholders to ensure consistent audit program implementation
Education
- Bachelor’s degree in Life Sciences, Engineering, or related field (required)
- CQA certification (preferred)
- Advanced degree (MS/PhD) in relevant field (preferred)
Benefits
- 99% company-paid medical, dental, and vision premiums
- Company-paid life insurance, AD&D, and disability benefits; voluntary plans available
- Dollar-for-dollar 401(k) match up to 6%
- Long-term stock incentives and Employee Stock Purchase Plan (ESPP)
- Discretionary quarterly bonus and flexible wellness benefit
- Generous PTO, paid holidays, and company-wide shutdowns
- Remote flexibility with required travel for role
Average salary estimate
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