This leadership role is fundamental in creating, building & motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards. It offers an opportunity to shape the DG landscape of Regeneron, driving innovation and excellence through data. The role will suit a visionary leader with a passion for data and a track record for driving success. The post-holder will set and implement a strategic vision for Regeneron’s data maturity roadmap including policies & procedures. They will lead the required change management program to enable the creation and embedding of a sustainable data quality culture across the organization. They will also be accountable for the Regeneron Industrial Operations and Product Supply (IOPS) DG program & serve as the global leader and subject matter expert on DG practices.
In this role, a typical day might include the following:
1. The creation & delivery of IOPS’ DG Program (Strategy, Engagement, Culture & Monitoring & Data Ops Leadership) for current and future sites & partners.
2. Adhering to current & evolving global standards using regulatory guidance & industrial intelligence, & generation of policies and procedures.
3. Senior Leadership Team (SLT) stakeholder engagement & holding the business to account in meeting the standards set.
4. Program Management.
5. Ensuring right to operate DG standards are continuously met.
6. Leading, driving and supporting with and through the business a mature DG culture.
7. Ensuring the DG function is appropriately resourced (internal & contract), supported and has the tools & direction to properly execute their function.
8. Delivering role model behaviors in promoting a DG culture across the organisation.
9. Staying updated on latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assessing the impact of these within IOPS.
10. Fostering a culture of quality & DG within the organisation.
11. Promoting the importance of DG across all departments.
12. Driving communication and collaboration between stakeholders to ensure effective DG practices.
13. Encouraging CI by actively seeking feedback and supporting initiatives designed to enhance data quality and governance.
14. Leading/supporting initiatives to embed DG principles into the company’s core values and everyday practices.
This role may be for you if you have:
1. Experience demonstrating the ability to partner, influence and incorporate new standards, or extensive experience in changing / revising large-scale program initiatives in the pharmaceutical or biotechnology industry.
2. Recent leadership experience in a data integrity or data governance role.
3. Previous people management and/or team leadership experience.
4. Experience leading cross functional teams and managing enterprise-wide data programs, operating and influencing across a global organization.
5. Significant leading change experience.
6. Experience in integrating cross-corporate processes, information strategies and designing strategic metrics and scorecards.
7. Demonstrated knowledge of applicable federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
8. Strong working knowledge of laboratory, manufacturing and support systems, and associated business processes.
9. Experience in a Quality organization (quality systems) and/or Manufacturing operations (Automation).
10. An understanding and experience in agile methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.).
To be considered for this role you must hold a BA/BS degree and the following amount of relevant experience for each level:
1. Sr Director: 15+ years.
2. Executive Director: 20+ years.
Equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT will also be considered. 50% travel required between sites based in Ireland and the USA.
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