Senior Manager, Clinical Quality Audit & Inspection Program

Role Summary

Senior Manager, Clinical Quality Audit & Inspection Program. This role leads the development and management of a global GCP, GPvP, and GCLP audit and inspection program to ensure compliance risk-based sponsor oversight and inspection readiness across clinical programs, trials, vendors, and investigator sites. Remote-friendly with travel as needed.

Responsibilities

• Develop standard operating procedures, work instructions, forms, and templates to support a fit-for-purpose clinical auditing and inspection management program aligned with GCP, GPvP, and GCLP.
• Develop dynamic, risk-based audit strategy and plan for critical sponsor processes, clinical trials, investigator sites, and vendors/CSPs.
• Plan, lead, conduct, document, report, and follow-up on clinical quality audits in accordance with regulations, guidance, contracts, and quality agreements.
• Ensure appropriate escalation to responsible management for critical audit findings and support.
• Provide education and guidance on audit processes and activities.
• Manage audit reports, findings, and CAPAs in the Veeva QMS and review/approve finding responses in the system.
• Develop and monitor audit finding response and CAPA timeliness metrics and present trends and improvement plans to senior management.
• Partner with departments to ensure consistent implementation and execution of the audit program.
• Work independently with respect to decision making and problem solving.

Qualifications

• 10+ years of experience in clinical quality assurance and GCP compliance.
• Bachelor’s degree in Life Sciences, Engineering, or a related field required; CQA certification is preferred.
• Strong knowledge and application of GCP, GVP, and GCLP.
• Ability to travel up to 40%-60% of time.
• Experience conducting audits of vendors and investigative sites.
• Excellent organizational, written, verbal, and presentation communication skills, including audit report writing and defense of findings.
• Experience in inspection readiness and preparation; experience hosting/regulatory authorities interactions.
• Critical thinking, prioritization, and ability to lead cross-functional teams; accountability for vendors/contractors and their deliverables.
• Proven track record in supporting regulatory inspections (FDA, EMA).

Education

• Bachelor’s degree in Life Sciences, Engineering, or related field. CQA certification preferred.

Additional Requirements

• The physical and mental requirements include regular computer use, clear communication, and occasional movement; reasonable accommodations may be provided.