AssociateDirector,GVPCompliance

## Accountabilities Lead and support the execution of the global GVP compliance strategy, ensuring alignment with regulatory expectations and internal quality standards. Conduct GVP audits and contribute to the development and continuous improvement of the global audit program. Partner with cross-functional teams to identify, assess, and mitigate pharmacovigilance compliance risks. Support preparation for and participation in health authority inspections, including mock inspections and readiness activities. Provide expert guidance on global PV regulations (FDA, EMA, ICH, GVP) and ensure their consistent application. Contribute to quality system enhancements, including PSMF updates and REMS compliance activities. Mentor and support junior team members while fostering a culture of compliance, accountability, and continuous improvement. Requirements: 8+ years of experience in a regulated healthcare or pharmaceutical environment, with strong focus on quality and compliance. Deep expertise in pharmacovigilance and Good Pharmacovigilance Practices (GVP), including exposure to global regulatory frameworks. Proven experience managing or supporting regulatory inspections and GVP/R&D audit programs. Strong understanding of quality management systems and pharmacovigilance operations, including risk management and signal detection concepts. Ability to work independently in a fast-paced, global environment with shifting priorities. Excellent communication skills with the ability to engage and influence senior leadership and cross-functional stakeholders. Strong analytical, strategic thinking, and decision-making capabilities. Bachelor’s degree in life sciences required; advanced degree preferred. Proficiency in MS Office and quality systems platforms. Benefits: Competitive annual compensation with performance-based bonus eligibility. Comprehensive health, dental, and vision insurance coverage. 401(k) retirement plan with employer contributions and matching. Generous paid time of