Job Description:
Your role plays a crucial part in ensuring the effective management and utilisation of Regeneron's data while maintaining compliance with regulatory requirements.
You will be instrumental in fostering a culture of data compliance and being accountable for developing comprehensive Data Governance (DG) policies and procedures across the organisation.
* Generate policies and procedures based on current and evolving global standards, ensuring alignment with global IOPS and adjusting established policies and practices.
* Work closely with Site Leads to create and define Key Performance Indicators (KPIs).
* Engage with senior leadership stakeholders and hold the business accountable for meeting set standards.
* Lead Program Management and ensure the DG (Policies & Programs) team is appropriately resourced, supported, and equipped to execute their function effectively.
* Establish strong relationships with Site Leads and their teams to facilitate clear communication and feedback loops.
* Support the preparation for regulatory inspections and audits related to DG by ensuring policies, procedures, and documentation are up-to-date and compliant.
* Assess and integrate DG practices in the context of IOPS-related mergers, acquisitions, and partnerships.
* Foster a culture of quality and DG within the organisation and promote the importance of data accuracy, reliability, and transparency across all departments.
* Facilitate communication and collaboration between stakeholders to ensure effective DG practices.
* Encourage Continuous Improvement (CI) 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.
This role may be suitable for you if you have:
* Knowledge of applicable federal, state, and local regulations, 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 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 organisation.
* Experience in 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 ability to adapt in the face of changing business needs.
* Recent leadership experience in a data integrity or data governance role.
To be considered for this role, you must 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.
Occasional travel to the US site is required.