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

Job Description

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI.  Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. 

The Position

Provide strategic leadership for the company's global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs by overseeing inspection readiness, regulatory inspection management, internal quality audits, and partner audit activities. Lead the Inspection Readiness and Management Program, serving as the primary Inspection Lead responsible for planning, hosting, facilitating, and directing regulatory inspections conducted by the FDA (BIMO), MHRA, PMDA, EMA, and other global Health Authorities, including Pharmacovigilance post-marketing inspections. Lead and execute a risk-based internal GCP/GVP audit program and oversee partner and alliance audits to evaluate compliance with applicable regulations, industry standards, and company procedures.

Partner with executive leadership and cross-functional stakeholders to maintain a continuous state of inspection readiness, ensure effective execution of regulatory inspections and audits, foster high-quality regulatory interactions, and drive timely responses to inspection and audit observations, CAPAs, and continuous improvement initiatives. Provide strategic leadership across Clinical Operations, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biometrics, Data Management, Quality, and external partners to promote sustainable compliance, operational excellence, and inspection success throughout the product development lifecycle.

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.
• 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.
• Lead all inspection planning activities including scope, logistics, agendas, inspection rooms, virtual inspection platforms, document management, and inspection communication plans.
• Facilitate and direct inspection management activities before, during, and after inspections, ensuring alignment across stakeholders and executive leadership.
• Chair daily inspection meetings, back room activities, issue escalation, risk assessments, and executive debriefs throughout inspections.
• 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.
• Lead and host partner, alliance, licensing, and due diligence audits by coordinating cross-functional stakeholders, managing audit planning and execution, facilitating auditor interactions, and ensuring timely responses to audit observations, commitments, and CAPAs.

  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.
• Demonstrated skills in the areas of project management, organization, and execution as well as priority setting.
• Highly motivated, strategic thinker with a focus on continuous improvement and innovation, who endeavors to anticipate and resolve problems.
• 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).
• Business travel approx. 25-30%

Preferred

• Advanced degree in life science preferred

California pay range

$145,000—$170,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.   

Candidates must have current, valid authorization to work in the country where this role is located.

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