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

Role: Lead global Clinical and Pharmacovigilance Quality Assurance, overseeing inspection readiness, regulatory inspections, internal audits, and partner audits to ensure compliance with GxP standards. Responsibilities: manage inspection planning, serve as primary Inspection Lead for agencies like FDA, EMA, MHRA, PMDA; facilitate mock inspections and prepare SMEs; oversee responses to inspection findings, CAPAs, and continuous quality improvement initiatives; lead risk-based internal GCP/GVP audits, and coordinate external partner audits. Collaborate with cross-functional leadership across Clinical Operations, PV, Regulatory, Medical Affairs, Biometrics, and Quality to sustain inspection readiness and operational excellence. Requirements: Bachelor's in life sciences, 8+ years in regulated pharma/biotech, with 5+ years in leadership; deep knowledge of GxP regulations including GCP and GVP, ICH, ISO; strong project management, communication, and leadership skills; proficiency with electronic quality systems. Preferred: advanced degree in life sciences. High-Value: global regulatory inspection management, GCP/GVP compliance, audit leadership, risk management, and experience supporting biopharma in late-stage development or post-marketing. WorkSetup: based in Pasadena, in-office 5 days/week; travel approximately 25-30%.