Senior Director GxP Audit

Job Summary

Leading the global strategy and execution of the GxP audit program, the full-time remote Senior Director GxP Audit will ensure compliance with GxP regulations and internal standards while managing a high-performing audit organization and collaborating with R&D Quality leadership and external partners.

Key Responsibilities

• Develop and execute a global, risk-based GxP audit strategy aligned with quality priorities
• Oversee audits of clinical trial processes and quality systems, ensuring compliance and effectiveness
• Utilize quality risk management principles to prioritize audits and present insights to executive leadership

Required Qualifications

• Doctorate degree with 5 years, Master's degree with 9 years, or Bachelor's degree with 11 years of experience in Quality Assurance or Strategy in a regulated industry
• At least 5 years of experience directly managing people or leading teams
• Deep knowledge of GxP regulations including GCP, GLP, and quality systems
• Demonstrated success in leading complex audit programs
• Strong executive communication and influencing skills