Job Description

Director, Pharmacovigilance Quality Assurance

Director, Pharmacovigilance Quality Assurance

This range is provided by SciPro. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$200,000.00/yr - $250,000.00/yr

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Divisional Principal Headhunter, Clinical Development

SciPro is partnered with a commercialized clinical-stage pharmaceutical company based in the Bay Area that's searching for a Director, Pharmacovigilance Quality Assurance to join their team full-time. This is a fantastic opportunity to work at an innovative and growing company with strong financial stability. Due to its commercial drug portfolio (soon to be expanded), the company’s revenue funds ongoing development.

This role will lead and manage day-to-day quality operations and compliance activities to support the success of drug safety processes, systems, training, and compliance programs for both development and marketed products.

Responsibilities:

• Lead Clinical Quality Assurance activities and collaborate with relevant teams to support the success of processes, systems, training, and compliance programs for both development and marketed products
• Champion and influence the management and growth of the Clinical Quality Assurance team, focusing on attracting and developing talent, creating a rewarding professional environment, and ensuring the team’s capabilities align with the company’s future needs
• Serve as a QA representative and support procedural and process compliance, providing advice and strategy aligned with global regulatory requirements
• Provide strategic and compliance advice; participate in the review and approval of required pharmacovigilance-related documents
• Oversee the pharmacovigilance quality management system (QMS), ensuring compliance with global regulatory standards (e.g., FDA, EMA, ICH, GxP)
• Collaborate with drug safety, IT, and other departments to ensure that safety databases are validated and maintained in compliance with regulatory requirements (e.g., 21 CFR Part 11)
• Perform ongoing gap assessments of the QMS and contribute to audit planning
• Develop, manage, and implement a risk-based audit plan for pharmacovigilance activities; conduct audits as necessary of processes, documentation, and service providers
• Set inspection readiness strategy and manage inspection readiness activities for pharmacovigilance functions

Requirements:

• BA/BS degree in biological sciences, pharmacy, related field, or equivalent experience
• 10+ years of experience
• Hands-on experience with safety database systems, including validation, audits, and compliance assessments

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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