Data Governance Role
Your role is fundamental in ensuring Regeneron's data is effectively managed and utilized while 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.
Responsibilities include:
* Supporting internal data audits to ensure inspection readiness and governance related to IOPS-related acquisitions;
* Establishing policies and procedures based on current and evolving global standards;
* Accountable for senior leadership stakeholder engagement and holding the business to account in meeting the standards set;
* Program Management and ensuring the DG (Policies & Programs) team is appropriately resourced, supported, and has the tools and direction to properly execute their function;
* Fostering a culture of quality and 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 continuous improvement 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.
Key Requirements:
* 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 across a global organization;
* Experience integrating cross-corporate processes, information strategies, and/or designing strategic metrics and scorecards;
* Strong analytical and problem-solving skills with exceptional attention to detail;
* Excellent communication and presentation skills, with the ability to convey complex concepts to non-technical audiences.
The ideal candidate should hold a BA/BS degree and 12+ years of professional experience or equivalent combination of education and experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.