Job Description

Director, Pharmacovigilance Quality Assurance

Redwood City, CA | Hybrid (3 days on-site)

Drive global PV compliance strategy at a fast-growing, clinical-stage biotech

A pioneering, commercial-stage biotechnology company focused on developing treatments for serious endocrine, oncologic, neurologic, and metabolic disorders is seeking a Director of Pharmacovigilance Quality Assurance.

With an expanding pipeline and a globally recognized product already on the market, this organization offers the chance to make a significant impact in a company on the rise.

Key Responsibilities:

• Lead QA activities supporting global drug safety and pharmacovigilance (DSPV) functions for both investigational and marketed products
• Oversee the DSPV quality management system (QMS) ensuring full GVP and GxP compliance
• Develop and implement a risk-based DSPV audit program, and prepare the organization for regulatory inspections
• Act as QA representative to provide compliance guidance across DSPV processes and documentation
• Lead non-compliance investigations, CAPAs, and trending analyses
• Oversee training, inspection readiness, and qualification of DSPV vendors and service providers
• Collaborate cross-functionally with Drug Safety, QA, IT, and Regulatory Affairs teams
• Mentor junior QA staff and contribute to long-term team development

Your Background:

• 10+ years in pharmacovigilance with 5+ years in quality assurance leadership
• Direct experience with GVP audits and managing regulatory inspections
• In-depth understanding of ICH, GVP, GxP, and global regulatory requirements
• Strong familiarity with safety database systems and validation (21 CFR Part 11)
• Demonstrated ability to write and enforce SOPs and manage CAPAs
• Excellent communication skills and ability to liaise with internal and external stakeholders
• Life sciences degree (or equivalent industry experience)

Why Join?

This is an opportunity to join a biotech company that’s achieving major clinical and commercial milestones, with a scientifically exciting pipeline and a stable financial foundation. You’ll be joining a purpose-driven organization that offers:

• A highly competitive benefits package, including full medical coverage for individuals and families
• Strong 401(k) matching and employee equity participation
• A supportive parental leave program and flexible time-off policy
• A collaborative and growing team where you can lead and influence key quality systems

If you are passionate about ensuring the highest standards in drug safety and want to shape QA strategy at a company making real-world impact - this could be your next big step.

Reach out to learn more or apply confidentially today.

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