This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, GVP Compliance based in the United States.
This senior-level role sits at the core of global pharmacovigilance quality and compliance, ensuring that patient safety standards are upheld across a complex, highly regulated pharmaceutical environment.
You will play a key role in shaping and executing Good Pharmacovigilance Practices (GVP) strategies, supporting both clinical and post-marketing activities.
The position involves close collaboration with global stakeholders to assess compliance risks, lead audits, and support regulatory inspections.
You will act as a subject matter expert, advising on global PV regulations while strengthening the organization’s quality systems and processes.
This is a highly visible role where your insights directly influence regulatory readiness and inspection outcomes.
You will contribute to continuous improvement initiatives that ensure robust patient safety and operational excellence across global markets.
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 off, including vacation, sick leave, and paid volunteer days.
- Strong focus on employee wellbeing and work-life balance programs.
- Opportunity to work in a global, mission-driven organization focused on rare disease innovation.
- Exposure to high-impact regulatory and compliance initiatives at an international scale.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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