Associate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance)

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing 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. The company focuses on innovative drugs for genetically based diseases, addressing conditions across therapeutic areas and pursuing targets not otherwise addressable by small molecules and biologics. Arrowhead leads in bringing RNAi-based therapies to diseases outside the liver, with a clinical pipeline targeting liver and lung diseases and a robust preclinical pipeline.

About the role

The Associate Director/Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance is a key leadership position responsible for overseeing PV quality, compliance, and alliance management activities. This role ensures inspection readiness and maintains a robust global compliance program within the Drug Safety & Pharmacovigilance department. Responsibilities include leading GVP inspections, collaborating with Quality Assurance (QA) on GCP, GVP, and GMP inspections, supporting issue reporting and CAPA development, and monitoring quality and compliance. The successful candidate will provide strategic direction, manage a team of PV Quality & Compliance professionals, and collaborate with cross-functional teams to enhance pharmaceutical product safety and quality.

Responsibilities

• Provide strategic guidance and leadership to the pharmacovigilance quality assurance team.
• Develop and implement a comprehensive quality assurance strategy aligned with organizational goals.
• Oversee end-to-end PV QA processes and systems to ensure compliance with regulatory requirements and internal policies/procedures.
• Proactively support Good Pharmacovigilance Practice (GVP) for clinical, post-marketing, and commercial activities, including PV/safety systems to protect patient safety, maintain data integrity, and implement Quality Systems.
• Monitor industry trends, regulatory changes, and best practices to drive continuous improvement of quality assurance processes.
• Monitor vendor key performance indicator (KPI) metrics and implement measures to enhance the quality of CROs and vendors.
• Lead the development, review, and maintenance of Standard Operating Procedures (SOPs) for pharmacovigilance quality assurance activities, ensuring consistency with current regulations, guidelines, and industry standards.
• Manage a team of quality assurance professionals, including training, mentoring, and performance evaluations, fostering a collaborative and high-performance work environment.
• Conduct regular internal audits of pharmacovigilance processes, systems, and data to ensure compliance with regulatory requirements.
• Collaborate with internal audit teams and external partners during regulatory inspections and audits.
• Develop and implement key quality metrics to assess the effectiveness of pharmacovigilance processes.
• Prepare and present quality assurance reports to senior management, highlighting trends, issues, and opportunities for improvement.
• Collaborate with cross-functional teams to assess and manage risks related to pharmacovigilance activities, identifying areas of potential risk and implementing mitigation strategies.
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of pharmacovigilance quality assurance activities.
• Regularly assess quality and compliance initiatives for effectiveness, outcomes, and relevance, adjusting strategy as needed based on results, risks, and feedback.
• Engage with stakeholders to solicit feedback and implement process enhancements.
• Monitor regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact PV systems.
• Oversee corrective and preventative actions (CAPA) development, execution, closure, and escalation for CAPAs associated with or impacting pharmacovigilance.
• Contribute to drug safety and pharmacovigilance issue management to support early issue detection, CAPA development, completion tracking, and effectiveness assessment for PV systems.

Requirements

• 10 years of experience in pharmacovigilance or drug safety, with 9-10 years in a quality assurance or compliance role.
• Bachelor’s Degree in a related scientific field.
• Strong understanding of global pharmacovigilance regulations, guidelines, and industry best practices.
• Proven experience in leading and managing teams, including demonstrated leadership skills and the ability to mentor and develop staff.
• Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external stakeholders.
• Detail-oriented with strong analytical and problem-solving capabilities.
• Experience in conducting internal audits and managing regulatory inspections is desirable.
• Proficiency in using pharmacovigilance databases and software.

Preferred Qualifications

• Advanced degree in pharmacy, life sciences, or a related field.

Pay

California pay range: $180,000—$230,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.