Director, Pharmacovigilance Quality

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:

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