Director, GMP Data Governance

The Director, GMP Data Governance role is fundamental in ensuring Regeneron’s data is effectively managed and utilized whilst remaining compliant with regulatory requirements. You will play a key role in fostering a data compliance culture and being accountable for developing comprehensive Data Governance (DG) policies and procedures across the organization. You will monitor the adoption of these policies and stay abreast of industry trends, technology advancements and external compliance decisions. Your remit will include supporting internal data audits, ensuring inspection readiness and governance related to IOPS related acquisitions.  

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

• Generation of policies and procedures based on current and evolving global standards, ensuring global IOPS alignment and adjusting established policies and practices

• Responsible with Site Leads for the creation and definition of KPIs  

• Accountable for senior leadership stakeholder engagement and holding the business to account in meeting the standards set 

• Accountable for Program Management and ensuring the DG (Policies & Programs) team is appropriately resourced, supported and has the tools and direction to properly execute their function 

• Establishing a successful relationship with Site Leads and their teams so a clear feedback loop is established 

• Supporting the preparation for regulatory inspections and audits related to DG by ensuring that policies, procedures, and documentation are up-to-date and compliant 

• Assessing and integrating DG practices in the context of IOPS related mergers, acquisitions, and partnerships 

• Fostering a culture of quality & DG within the organisation and promoting the importance of data accuracy, reliability and transparency across all departments  

• Facilitating 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  

This role may be for you if you have:

• 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  

• Demonstrable ability to oversee the creation of global policies, procedures and standards both with and through the business 

• Extensive experience demonstrating the ability to partner, influence and incorporate new standards  

• Extensive experience in changing / revising large-scale program initiatives in the pharmaceutical or biotechnology industry  

• Experience leading cross functional teams and managing enterprise-wide data programs, operating and influencing a