Senior Manager, Clinical Quality Audit & Inspection Program
About The Position
Praxis is hiring a diligent, detail-driven quality leader with a sharp eye for compliance risk, operational rigor, and inspection readiness to serve as Senior Manager, Clinical Quality Audit & Inspection Programs. You will own the development and management of a global GCP, GPvP, and GCLP audit and inspection program and related plan to ensure compliance risk-based sponsor oversight and monitoring in accordance with global regulations, guidance, and company policies. You'll provide leadership to, and partner with, cross-functional stakeholders to ensure inspection readiness and remediation of audit and inspection observations across clinical programs and trials, vendors, investigator sites, and critical processes.
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) is required
- 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 which must include 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
- 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).
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 (GcLP)
- Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and systens, clinical trials, investigator sites, and vendors / contract service providers (CSPs)
- Plan, lead, conduct, document, report, and follow-up of 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
Benefits
- 99% of the premium paid for medical, dental and vision plans
- company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
- dollar-for-dollar match up to 6% on eligible 401(k) contributions
- long-term stock incentives and ESPP
- discretionary quarterly bonus
- extremely flexible wellness benefit
- generous PTO
- paid holidays and company-wide shutdowns
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
