Senior Manager, Clinical Quality Audit – Inspection Program
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Job Description
Senior Manager, Clinical Quality Audit & Inspection Programs overseeing compliance in clinical programs. Ensuring inspection readiness and remediation of audit observations within clinical operations.
Responsibilities:
- Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program to ensure compliance with Good Clinical Practice(GCP)/Good Pharmacovigilance Practice(GPvP)/Good Clinical Laboratory Practice (GpLP).
- Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and systems, clinical trials, investigator sites, and vendors/contract service providers (CSPs).
- Plan, lead, conduct, document, report, and follow-up on clinical quality audits according to regional compliance 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 Veeva Quality Management System (QMS) and review and approve finding responses and actions in system.
- Develop and monitor audit finding response and CAPA timeliness performance metrics and present trends and improvement plans to senior management.
- Partner with departments across organizations to ensure consistent implementation and execution of audit program.
- Work independently with respect to decision making and problem solving.
Requirements:
- 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 Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Clinical Laboratory Practice (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, presentation, and defense of findings.
- Experience in inspection readiness and preparation.
- Experience hosting and interacting with regulatory authorities.
- Critical thinking and prioritization skills.
- Experience managing and being accountable for vendors/contractors and their deliverables.
- Proven ability to lead cross-functional teams and drive continuous improvement.
- Proven track record and experience in supporting regulatory inspections (FDA, EMA).
Benefits:
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance.
- AD&D benefits.
- Disability benefits.
- Voluntary plans to personalize your coverage.
- 401(k) matching up to 6% on eligible contributions.
- Long-term stock incentives.
- Employee Stock Purchase Program (ESPP).
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous PTO.
- Paid holidays.
- Company-wide shutdowns.
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