Global Data Governance Team Lead
This leadership role is fundamental in creating, building and motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards.
Key Responsibilities:
* Set and implement a strategic vision for Regeneron's data maturity roadmap, including policies and procedures.
* Lead the required change management program to enable the creation and embedding of a sustainable data quality culture across the organization.
* Be accountable for the Regeneron Industrial Operations and Product Supply (IOPS) DG program and serve as the global leader and subject matter expert on DG practices.
A typical day might include:
* The creation and delivery of IOPS' DG Program (Strategy, Engagement, Culture and Monitoring and Data Ops Leadership) for current and future sites and partners.
* Adhering to current and evolving global standards using regulatory guidance and industrial intelligence, and generation of policies and procedures.
* Senior Leadership Team (SLT) stakeholder engagement and holding the business to account in meeting the standards set.
* Program Management: ensuring right to operate DG standards are continuously met.
* Leading, driving and supporting with and through the business a mature DG culture.
* Ensuring the DG function is appropriately resourced (internal and contract), supported and has the tools and direction to properly execute their function.
* Delivering role model behaviors in promoting a DG culture across the organisation.
* Staying updated on latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assessing the impact of these within IOPS.
* Fostering a culture of quality and DG within the organisation.
* Promoting the importance of DG across all departments.
* Driving communication and collaboration between stakeholders to ensure effective DG practices.
* Encouraging CI by actively seeking feedback and supporting initiatives designed to enhance data quality and governance.
* Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices.
Requirements:
* 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.
* Recent leadership experience in a data integrity or data governance role.
* Previous people management and/or team leadership experience.
* Experience leading cross-functional teams and managing enterprise-wide data programs, operating and influencing across a global organization.
* Significant leading change experience.
* Experience in integrating cross-corporate processes, information strategies and designing strategic metrics and scorecards.
* 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.
Education and Experience:
* Bachelor's degree or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as data management and operations, quality assurance, compliance, manufacturing operations, quality control, or IT.
50% travel required between sites based in Ireland and the USA.