Arrowhead Pharmaceuticals
Senior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management)
Pasadena, California, United States · Senior
Sponsorship not specified$25k-$30kDetected 4 days ago
GCPProject ManagementAuditingLogisticsFDA RegulatoryPharmacovigilanceResearchAnimal StudiesLeadershipCommunicationMentoringInternal AuditGxPRegulatory Affairs
About the role
- This role is based in Pasadena with an expectation to be in office 5 days a week.
Responsibilities
- Own the global GCP/GVP Inspection Readiness Program and establish governance that maintains continuous inspection readiness.
- Lead all inspection planning activities including scope, logistics, agendas, inspection rooms, virtual inspection platforms, document management, and inspection communication plans.
- Lead preparation of SMEs and executives through mock inspections, interview coaching, inspection simulations, and readiness assessments.
- Oversee regulatory document requests, quality review of submissions, and consistency of inspection responses.
- Lead cross-functional development of responses to Form FDA 483 observations and equivalent findings, CAPAs, effectiveness checks, and regulatory commitments.
- Provide strategic oversight of CROs, vendors, and business partners to ensure inspection readiness and inspection support.
- Develop and present inspection readiness dashboards, KPIs, risk metrics, and trend analyses to Quality and Executive Leadership.
- Lead implementation of new global regulatory expectations including ICH E6(R3), FDA, EMA, MHRA, PMDA, and GVP guidance.
- Drive continuous improvement initiatives that strengthen inspection readiness, quality systems, and operational excellence.
- Develop, implement, and lead a risk-based GCP and Pharmacovigilance (GVP) internal audit program, including planning, conducting, reporting, and overseeing corrective and preventive actions (CAPAs) to assess compliance, identify risks, and drive continuous quality improvement.
Requirements
- Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
- Minimum of eight (8) years of experience in the regulated pharmaceutical and/or biotechnology industry, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility.
- Full knowledge of GxP regulations, including GCP/GVP (FDA, EU, etc.), ICH guidelines, and ISO standards.
- Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels.
- Previous experience with the use of electronic document / quality management systems (EMDS / EQMS).
- Candidates must have current, valid authorization to work in the country where this role is located.
Nice to have
- Advanced degree in life science preferred
Compensation
- California pay range
Benefits
- Serve as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections, including PV post-marketing surveillance inspections.
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