Job Description
Your role is fundamental in ensuring Regeneron's data is effectively managed and utilized whilst remaining compliant with regulatory requirements.
Key Responsibilities
* Develop comprehensive Data Governance (DG) policies and procedures across the organization.
* Monitor the adoption of these policies and stay abreast of industry trends, technology advancements, and external compliance decisions.
* Support internal data audits, ensure inspection readiness, and governance related to IOPS acquisitions.
Typical Day
1. Generate policies and procedures based on current and evolving global standards, ensuring global IOPS alignment.
2. Create and define KPIs with Site Leads.
3. Hold senior leadership stakeholders accountable for meeting standards set.
4. Program manage the DG team, ensuring they are appropriately resourced, supported, and have the tools and direction to execute their function.
5. Establish a relationship with Site Leads and their teams for a clear feedback loop.
6. Support preparation for regulatory inspections and audits by ensuring policies, procedures, and documentation are up-to-date and compliant.
7. Assess and integrate DG practices in the context of IOPS mergers, acquisitions, and partnerships.
8. Foster a culture of quality & DG within the organization.
9. Facilitate communication and collaboration between stakeholders for effective DG practices.
Requirements
* Knowledge of applicable federal, state, and local regulations, rules, policies, and procedures such as GDPR, FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
* Demonstrable ability to oversee the creation of global policies, procedures, and standards.
* Extensive experience demonstrating the ability to partner, influence, and incorporate new standards.
* Experience leading cross-functional teams and managing enterprise-wide data programs.
* Excellent communication and presentation skills, with the ability to convey complex concepts to non-technical audiences.