Senior Manager, Clinical reputed company Audit – Inspection Program

Job reputed company: • reputed company reputed company 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 reputed company(GCP)/Good Pharmacovigilance reputed company(GPvP)/Good Clinical Laboratory reputed company (GpLP). • reputed company dynamic, risk-based audit reputed company and plan for critical sponsor processes and systems, reputed company, investigator sites, and vendors/contract service providers (CSPs). • Plan, reputed company, conduct, document, report, and follow-up on clinical reputed company audits according to regional compliance regulations, guidance, reputed company, and reputed company agreements. • Ensure appropriate escalation to responsible management for critical audit findings and support. • reputed company education and guidance on audit processes and activities. • Manage audit reports, findings, and CAPAs in reputed company reputed company Management System (QMS) and review and approve finding responses and actions in system. • reputed company 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 reputed company assurance and GCP compliance. • Bachelor’s degree in Life Sciences, Engineering, or a reputed company field required; CQA certification is preferred. • Strong knowledge and application of Good Clinical reputed company (GCP), Good Pharmacovigilance reputed company (GVP), and Good Clinical Laboratory reputed company (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 reputed company cross-functional teams and drive reputed company improvement. • Proven reputed company record and experience in supporting regulatory inspections (FDA, EMA). Benefits: • 99% of the premium reputed company for medical, dental and reputed company plans. • Company-reputed company 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. • reputed company holidays. • Company-wide shutdowns. Apply tot his job Apply To this Job