Compliance

• Championing the implementation of Global Quality vision, policies, processes, and decisions
• Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
• Continually enhance partnerships with key stakeholders and leaders across the business
• Support and drive the implementation of quality and compliance projects and objectives
• Stay updated on regulations and recommend proactive compliance changes when necessary
• Develop and enhance GVP Compliance processes and best practices
• Lead the execution of the GVP Compliance Global Audit Program
• Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
• Provide insights to continually optimize the GVP Compliance Audit Program
• Contribute to Pharmacovigilance System Master File (PSMF) updates
• Core team member and key contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
• Create a high-functioning team to ensure GVP compliance and foster a culture of teamwork and mutual respect
• Mentor and develop staff to achieve their full potential
• Conduct management activities, including staffing, budget monitoring, and strategic planning
• Manage recruiting, hiring, and evaluations with HR and Global Quality leadership

Director, GVP Compliance

Regulatory Food Scientist IV

Associate Regulatory Affairs Specialist

Regulatory Manager, Pharma

Healthcare Payer Compliance Specialist

Senior Director of Regulatory Affairs