Chief GMP Data Integrity Officer

1 month ago

Ireland Regeneron Pharmaceuticals, Inc Full time

We are currently looking to fill a Sr Director/Executive Director, Chief GMP Data Integrity Officer position. This position is responsible for the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program and directs and leads the activities of the team. You will work closely with business leaders and department subject matter experts to implement data integrity standards into business operations and be the global leader on good practices for their area. Your remit will include developing and delivering effective training and education programs; working with the business to embed practical steps into procedures, processes and other documentation.

In this role, a typical day might include the following:

Business Priorities:
  • Global owner and lead for Data Governance and Integrity – defines the standard and ensures broad understanding and integration across the business.
  • Partners with personnel to define or revise associated business processes to meet defined standards; applies practical education and fosters a culture of documenting processes.
  • Works with department management to build a robust data governance program, champion an inspection ready approach and ensure documentation generation and maintenance all supporting compliant data practices.
  • Participates in Regulatory Agency interactions and preparation as related to site inspections and ensures regulatory observations are adequately addressed and completed on schedule.
  • Keeps current on the changing industry landscape and incorporates those findings to continuously improve Regeneron practices and procedures; knowledgeable of process and forensic-based auditing techniques for data integrity.
Operational Oversight:
  • Establishes departmental goals aligned with organization goals.
  • Builds global relationships to gain direct knowledge of operations and influence integration of data integrity standards and continuous improvements of departmental data integrity processes.
  • Provides mentorship to employees for performance and development.
  • Interviews, hires, orients, and trains incoming personnel.
  • Ensures direct-report staff are appropriately resourced, supported and have the tools and direction to properly complete their function.
  • Establishes programs, procedures, and work instructions to lead the data governance program including metrics, reports, inspection readiness, and both conceptual and practical education.
  • Understands data integrity risks and regularly guides departments on requirements and works on the solution; escalates risks to executive leadership on a regular basis.
Business Leadership:
  • Provides leadership and collaboration within and across the organization at all levels, across functional groups for all data integrity matters.
  • Partners with global counterparts to ensure global alignment of processes, systems and procedures, unified communication to user areas, and identification of enhancements.
  • Integrates across IOPS business areas with an eye to gain practical understanding of day-to-day operations.
  • Coaches, mentors, and guides staff on changing standards.
  • Identifies risks to operations and collaboratively works with team and business to identify and implement mitigations.
  • Rigorously adheres to organizational basics – models to others the importance of getting the basics right, and reinforcing that standard.
  • Develops personnel, supports a positive, diverse, equal, and inclusive work environment, and builds a strong team.
Technology & Systems:
  • Responsible for the technology and systems that support the QA team.
Health & Metrics:
  • Reports status of process performance and ensures timely and accurate metrics for presentation; includes day-to-day operations, program health, status, and action, as well as management review (Right to Operate).

This role may be for you if you:

  • Have outstanding experience demonstrating ability to partner, influence and incorporate new standards, or extensive experience in changing / revising large-scale program initiatives in the pharmaceutical or biotechnology industry.
  • Have knowledge of one or more of the following pharmaceutical or biotech areas: Manufacturing, Quality Control, Quality Assurance, or Information Technology.
  • Are knowledgeable in applicable federal, state, and local regulations, rules, policies, and procedures such as FDA Guidance on Data Integrity, MHRA Data Integrity Guide, and WHO Guide to Data Integrity.
  • Are able to capture relevant facts, assess, and decide to implement; understands impact to areas and seeks input.
  • Have the ability to influence and lead with and without direct line authority.
  • Are skilled in analyzing information of considerable difficulty and drawing valid conclusions.
  • Demonstrate leadership skills and strong interpersonal skills; ability to coach, mentor and build up team members.
  • Can translate ambiguity into action plans for teams.

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience for each level:

  • Sr Director: 15+ years.
  • Executive Director: 20+ years.

Recent leadership experience in a data integrity or data governance role is required. Previous people management and/or team leadership experience required. May substitute proven experience for education requirement. Travel required between sites based in Ireland and the USA.

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