Arrowhead Pharmaceuticals

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

San Diego, California, United States · Director

Sponsorship not specified$180k-$230kDetected 18 days ago

GCPComplianceAuditingGMPPharmacovigilanceResearchAnimal StudiesLeadershipCommunicationProblem SolvingMentoringInternal Audit

About the role

The Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Drug Safety & Pharmacovigilance department.
This position will lead preparation, delivery, and response to GVP inspections, work closely with QA to ensure Patient Safety input to GCP, GVP, GMP inspections, support issue reporting and CAPA development, monitor quality and compliance.
The successful candidate will provide strategic direction, manage a team of PV Quality & Compliance professionals as applicable, and collaborate with cross-functional teams to enhance the safety and quality of pharmaceutical products.

Develop and implement a comprehensive quality assurance strategy aligned with organizational goals.
Develop/oversee execution of (end-to-end) PV QA processes and systems to ensure compliance/alignment with regulatory requirements and internal policies/procedures.
Proactively provide Good Pharmacovigilance Practice (GVP) support for clinical, post marketing and commercial activities including PV/ safety systems to protect patient safety and well-being, maintain data integrity, and support implementation of Quality Systems.
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.
Manage a team of quality assurance professionals, including training, mentoring, and performance evaluations.
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.

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.
Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external stakeholders.
Experience in conducting internal audits and managing regulatory inspections is desirable.
Proficiency in using pharmacovigilance databases and software.
Advanced degree in pharmacy, life sciences, or a related field
Candidates must have current, valid authorization to work in the country where this role is located.

Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

Ensure that SOPs are consistent with current regulations, guidelines, and industry standards.

This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.