Senior Director, GMP/GDP Compliance

Job Summary

Leading the global GMP/GDP audit organization and predictive compliance intelligence capability, the full-time remote Senior Director, GMP/GDP Compliance will establish strategic direction, oversee audit execution, and build predictive models to enhance compliance risk management.

Key Responsibilities

• Serve as the accountable leader for the global GMP/GDP audit organization and predictive compliance intelligence capability
• Establish the strategic direction, operating model, and multiyear roadmap for audit and compliance intelligence functions
• Develop predictive models and dashboards to guide audit priorities and proactive interventions for compliance risks

Required Qualifications

• Doctorate degree and 5 years of biologics manufacturing and regulatory compliance experience, or
• Master's degree and 9 years of biologics manufacturing and regulatory compliance experience, or
• Bachelor's degree and 11 years of biologics manufacturing and regulatory compliance experience
• At least 5 years of experience directly managing people or leading teams and projects
• Significant leadership experience in pharmaceutical or biotechnology Quality, auditing, compliance, or related disciplines