Praxis

Compensation

Full Description

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.