Associate Director, GVP Compliance
Based in the United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 8+ years
- Required Skills
- Risk Management
Requirements
- 8+ years of experience in a regulated healthcare or pharmaceutical environment
- Deep expertise in pharmacovigilance and Good Pharmacovigilance Practices (GVP)
- Experience managing or supporting regulatory inspections and GVP/R&D audit programs
- Understanding of quality management systems and pharmacovigilance operations
- Ability to work independently in a fast-paced, global environment
- Excellent communication skills
- Strong analytical and strategic thinking capabilities
- Bachelor’s degree in life sciences required; advanced degree preferred
- Proficiency in MS Office and quality systems platforms
Responsibilities
- Lead and support the execution of the global GVP compliance strategy
- Conduct GVP audits and contribute to the global audit program
- Partner with cross-functional teams to mitigate pharmacovigilance compliance risks
- Support preparation for and participation in health authority inspections
- Provide expert guidance on global PV regulations (FDA, EMA, ICH, GVP)
- Contribute to quality system enhancements including PSMF updates
- Mentor and support junior team members
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