Associate Director/Director of Quality & Compliance in Drug Safety and Pharmacovigilance

About the Company

Arrowhead Pharmaceuticals, Inc. is a publicly traded biopharmaceutical firm specializing in innovative RNA interference (RNAi) treatments aimed at silencing genes responsible for difficult-to-treat diseases. Their technologies harness RNAi pathways to selectively inhibit gene expression, targeting disease-causing proteins. With headquarters in Pasadena, CA and research hubs in Madison, WI and San Diego, CA, the company is advancing therapies for genetic diseases, including liver and lung indications.

Role Overview

The Associate Director or Director of Quality & Compliance within the Drug Safety and Pharmacovigilance (PV) unit will lead quality assurance and compliance efforts globally. This role is essential for maintaining robust inspection readiness and a comprehensive compliance framework. The position demands collaboration across teams to uphold patient safety, ensure data integrity, and support regulatory adherence throughout clinical development and commercial operations.

Key Responsibilities

• Provide strategic leadership and oversight to pharmacovigilance quality assurance functions aligned with corporate objectives.
• Design, implement, and manage end-to-end PV quality assurance processes ensuring regulatory and internal policy compliance.
• Deliver Good Pharmacovigilance Practice (GVP) guidance supporting clinical, post-marketing, and commercial safety systems to safeguard patients and assure data accuracy.
• Continuously monitor industry trends, regulatory updates, and best practices to enhance quality frameworks.
• Evaluate vendor performance using KPIs and strengthen quality controls for Contract Research Organizations (CROs) and other suppliers.
• Develop, review, and maintain SOPs for PV quality assurance activities in compliance with current regulations and standards.
• Lead, mentor, and assess a team of quality assurance professionals fostering a collaborative, high-output environment.
• Conduct internal audits of pharmacovigilance processes and data, coordinate external inspections and audits with stakeholders.
• Establish and track quality metrics to measure PV process effectiveness, reporting insights and improvement opportunities to senior leadership.
• Identify and mitigate risks related to pharmacovigilance by collaborating with cross-functional groups and instituting proactive controls.
• Drive ongoing quality improvements and adjustments to compliance initiatives based on results and feedback.
• Oversee CAPA processes from development to closure, including escalation management as needed.
• Support drug safety issue management by facilitating early detection, CAPA tracking, and system effectiveness evaluation.
• Monitor emerging global regulations affecting PV systems to ensure organizational readiness.

Candidate Requirements

• Minimum of 10 years’ experience in pharmacovigilance or drug safety, with 9-10 years focused specifically on quality assurance or compliance.
• Bachelor’s degree in a related scientific discipline; advanced degrees in pharmacy or life sciences preferred.
• Comprehensive knowledge of global pharmacovigilance regulatory requirements, guidelines, and best practices.
• Demonstrated leadership capability with experience managing and developing teams.
• Exceptional written and verbal communication skills enabling effective collaboration with internal and external stakeholders.
• Strong attention to detail combined with analytical and problem-solving strengths.
• Experience with internal audits and regulatory inspection management is highly desirable.
• Proficiency using pharmacovigilance databases and relevant software tools.

Compensation and Additional Information

In California, this role offers a salary range between $180,000 and $230,000 USD annually. Arrowhead provides competitive remuneration and a comprehensive benefits package. Applicants must have valid work authorization for the United States. The position is based onsite in San Diego, California.