Job Description

Director, Pharmacovigilance Quality

Hybrid Role - 3x per week in Redwood City, CA

Key Responsibilities

• Oversee the development and implementation of pharmacovigilance (PV) quality and compliance programs to ensure adherence to global regulatory requirements.
• Lead internal and external audits, inspections, and quality assessments, identifying areas for improvement and ensuring corrective and preventive actions (CAPAs) are effectively implemented.
• Develop and maintain pharmacovigilance quality management systems (QMS), including policies, procedures, and training programs, to drive a culture of compliance and continuous improvement.
• Collaborate with cross-functional teams, including regulatory affairs, drug safety, and clinical operations, to align PV quality initiatives with broader organizational goals.

Key Qualifications

• 10+ years of relevant industry experience, 5+ specifically in a PV leadership role
• Proven experience in audit and inspection management
• Experience supporting GVP QA for clinical and commercial-stage companies
• Experience developing SOP's for GVP SOP's and provide trainings to relevant stakeholders

Please reach out to Ryan Moran to learn more about this opportunity:

✉: ryan.moran@peoplewithchemistry.com

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