Job Summary
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.
Key Responsibilities
* Set and implement a strategic vision for Regeneron's data maturity roadmap including policies & 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 & serve as the global leader and subject matter expert on DG practices.
Typical Day
* Create & deliver IOPS' DG Program (Strategy, Engagement, Culture & Monitoring & Data Ops Leadership) for current and future sites & partners.
* Adhere to current & evolving global standards using regulatory guidance & industrial intelligence, & generate policies and procedures.
* Engage with Senior Leadership Team (SLT) stakeholders and hold the business to account in meeting the standards set.
* Manage programs and ensure right to operate DG standards are continuously met.
* Lead, drive and support a mature DG culture within the business.
* Ensure the DG function is appropriately resourced (internal & contract), supported and has the tools & direction to properly execute their function.
* Deliver role model behaviors in promoting a DG culture across the organisation.
* Stay updated on latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assess the impact of these within IOPS.
* Foster a culture of quality & DG within the organisation.
* Promote the importance of DG across all departments.
* Drive communication and collaboration between stakeholders to ensure effective DG practices.
* Encourage Continuous Improvement by actively seeking feedback and supporting initiatives designed to enhance data quality and governance.
* Lead/support initiatives to embed DG principles into the company's core values and everyday practices.
Requirements
* Demonstrate experience partnering, influencing and incorporating new standards, or extensive experience in changing / revising large-scale program initiatives in the pharmaceutical or biotechnology industry.
* Have recent leadership experience in a data integrity or data governance role.
* Hold 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.
* Integrate cross-corporate processes, information strategies and designing strategic metrics and scorecards.
* Demonstrated knowledge of applicable federal, state, and local regulations.
* Strong working knowledge of laboratory, manufacturing and support systems, and associated business processes.
* Experience in a Quality organization (quality systems) and/or Manufacturing operations (Automation).
* An understanding and experience in agile methodologies.
Education
* A BA/BS degree.
* Relevant experience:
o Sr Director: 15+ years.
o 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.