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Director, Pharmacovigilance QA
162874
Posted:
28/03/2025
Email: ryan.moran@meetlifesciences.com
- Competitive
- , United States
- Permanent
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 QA 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
Email: ryan.moran@meetlifesciences.com
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