Senior Manager, Clinical Quality Audit – Inspection Program
Job Description:
• 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.
Apply Now
Apply Now
• 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.
Apply Now
Apply Now