Compliance

• Develop and implement comprehensive quality management systems and processes to ensure compliance with regulatory requirements, industry standards, and company policies.
• Lead internal and external audits and inspections, including planning, execution, and follow-up activities to address findings and ensure timely resolution.
• Conduct regular quality reviews of clinical trial documentation, protocols, and study reports, identifying areas for improvement and implementing corrective actions as necessary.
• Provide leadership and guidance to the clinical quality compliance team, including training, mentoring, and performance management.
• Collaborate with cross-functional teams to assess quality risks, develop risk mitigation strategies, and drive continuous improvement initiatives.

Clinical Quality Compliance Lead

Senior Regulatory Risk Specialist

Director, Global Regulatory Leader

Director, Global Regulatory Leader

Senior Manager, Quality – Regulatory Affairs

Senior Compliance Lead