Executive Director, GMP Data Governance & Integrity

$196,100 - $385,700/Yr

Regeneron Pharmaceuticals - Troy, NY

Full-time - Senior

Troy, NY

Professional, Scientific, and Technical Services

About the position

The Sr/Executive Director, GMP Data Governance & Integrity position at Regeneron is responsible for leading the Data Governance and Integrity program within the Industrial Operations and Product Supply (IOPS) division. This role involves directing a team, collaborating with business leaders to implement data integrity standards, and ensuring compliance with regulatory requirements. The position also focuses on developing training programs, fostering a culture of documentation, and continuously improving practices related to data integrity across the organization.

Responsibilities

• Define and ensure broad understanding and integration of data governance and integrity standards across the business.
• Partner with personnel to define or revise business processes to meet defined standards and foster a culture of documenting processes.
• Build a robust data governance program and ensure documentation generation and maintenance supporting compliant data practices.
• Participate in Regulatory Agency interactions and ensure regulatory observations are addressed on schedule.
• Establish departmental goals aligned with organizational goals and build global relationships to influence integration of data integrity standards.
• Provide mentorship to employees and ensure direct-report staff is appropriately resourced and supported.
• Establish programs, procedures, and work instructions to lead the data governance program, including metrics and reports.
• Guide departments on data integrity risks and escalate risks to executive leadership regularly.
• Provide leadership and collaboration across the organization for all data integrity matters.
• Develop personnel and support a positive, diverse, equal, and inclusive work environment.

Requirements

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

Nice-to-haves

• Knowledge of Manufacturing, Quality Control, Quality Assurance, or Information Technology in the pharmaceutical or biotech areas.
• 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 for eligible employees