Executive Director, GMP Data Governance & Integrity

$196,100 - $385,700/Yr

Regeneron Pharmaceuticals - Troy, NY

Full-time - Senior

Troy, NY

5,001-10,000 employees

Professional, Scientific, and Technical Services

About the position

The Sr/Executive Director, GMP Data Governance & Integrity at Regeneron Pharmaceuticals is responsible for leading the Data Governance and Integrity program within the Industrial Operations and Product Supply (IOPS) division. This role involves establishing data integrity standards, collaborating with business leaders, and ensuring compliance with regulatory requirements. The position also includes developing training programs, mentoring staff, and overseeing operational processes to maintain high standards of data governance across the organization.

Responsibilities

• Direct and lead the activities of the Data Governance and Integrity team.
• Define and ensure broad understanding and integration of data integrity standards across the business.
• Partner with personnel to revise business processes to meet defined standards.
• Build a robust data governance program and ensure documentation generation and maintenance.
• Participate in Regulatory Agency interactions and ensure timely resolution of regulatory observations.
• Establish departmental goals aligned with organizational goals.
• Provide mentorship and support to employees for performance and development.
• Develop and deliver effective training and education programs.
• Report on process performance and ensure timely and accurate metrics for management review.

Requirements

• Bachelor's degree in a relevant field.
• 15+ years of experience for Sr Director level or 20+ years for Executive Director level.
• Recent leadership experience in a data integrity or data governance role.
• Previous people management and/or team leadership experience.

Nice-to-haves

• Knowledge of pharmaceutical or biotech areas such as Manufacturing, Quality Control, Quality Assurance, or Information Technology.
• Familiarity with FDA Guidance on Data Integrity, MHRA Data Integrity Guide, and WHO Guide to Data Integrity.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off