Senior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management)

The Position Provide strategic leadership for the company’s global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs, including inspection readiness, regulatory inspection management, internal quality audits, and partner audit activities. Lead the Inspection Readiness and Management Program as the primary Inspection Lead for FDA (BIMO), MHRA, PMDA, EMA, and other global Health Authority inspections (including PV post-marketing inspections). Lead and execute a risk-based internal GCP/GVP audit program and oversee partner/alliance audits to evaluate compliance with regulations, industry standards, and company procedures. Responsibilities Own the global GCP/GVP Inspection Readiness Program and establish governance for continuous readiness. Serve as primary Inspection Lead and Host for health authority inspections (including PV post-marketing surveillance). Lead inspection planning (scope, logistics, agendas, virtual platforms, document management, communications). Facilitate inspection management before/during/after inspections; chair daily meetings and debriefs. Prepare SMEs/executives via mock inspections, interview coaching, simulations, and readiness assessments. Oversee regulatory document requests, submission quality reviews, and response consistency. Lead responses to Form FDA 483/equivalent findings, CAPAs, effectiveness checks, and regulatory commitments. Provide oversight of CROs/vendors/business partners to ensure inspection support. Develop and present inspection readiness dashboards, KPIs, and risk/trend analyses. Implement new global regulatory expectations (ICH E6(R3), FDA, EMA, MHRA, PMDA, GVP). Drive continuous improvement initiatives for inspection readiness and quality systems. Develop and lead risk-based GCP/GVP internal audits, including CAPA oversight. Lead/host partner, alliance, licensing, and due diligence audits. Location Pasadena; expectation to be in office 5 days/week. Requirements Bachelor’s degree in life sciences, pharmacy, chemistry, or related. 8+ years regulated pharma/biotech experience; 5+ years in leadership with increasing responsibility. Full knowledge of GxP (including GCP/GVP), ICH, and ISO standards. Project management, organization/execution, and priority-setting skills. Strategic, continuous-improvement mindset; ability to anticipate/resolve problems. Excellent communication/interpersonal/leadership skills; influence stakeholders. Experience with EMDS/EQMS. Business travel ~25–30%. Preferred Advanced degree in life science. Compensation California pay range: $145,000–$170,000 USD. #J-18808-Ljbffr Scorpion Therapeutics