Data Governance Lead
As a Data Governance Lead at Regeneron, your role is crucial in ensuring the effective management and utilization of company data while maintaining compliance with regulatory requirements. You will be instrumental in fostering a culture of data compliance and accountability for developing comprehensive Data Governance policies and procedures across the organization.
Key Responsibilities:
* Developing policies and procedures based on current global standards to ensure alignment with IOPS regulations.
* Collaborating with Site Leads to create Key Performance Indicators (KPIs).
* Maintaining senior leadership stakeholder engagement and holding the business accountable for meeting set standards.
* Leading Program Management and ensuring the Data Governance team has the necessary resources and tools to execute their function effectively.
* Fostering relationships with Site Leads and their teams to establish a clear feedback loop.
* Supporting preparation for regulatory inspections and audits by ensuring up-to-date policies, procedures, and documentation.
* Integrating Data Governance practices into IOPS-related mergers, acquisitions, and partnerships.
* Promoting a culture of quality and data accuracy, reliability, and transparency across all departments.
* Facilitating communication and collaboration between stakeholders to ensure effective Data Governance practices.
* Encouraging Continuous Improvement (CI) through feedback and supporting initiatives to enhance data quality and governance.
* Embedding Data Governance principles into the company's core values and everyday practices.
Requirements:
* 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.
* Ability to oversee the creation of global policies, procedures, and standards within the business.
* Extensive experience in partnering, influencing, and incorporating new standards.
* Leadership experience in changing or revising large-scale program initiatives in the pharmaceutical or biotechnology industry.
* Experience leading cross-functional teams and managing enterprise-wide data programs.
* Strong analytical and problem-solving skills with attention to detail.
* Excellent communication and presentation skills.
* Adaptability in the face of changing business needs.
* Recent leadership experience in a data integrity or data governance role.
Qualifications:
* BA/BS degree or equivalent combination of education and experience.
* 12+ years of professional experience in pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.
This role may require occasional travel to the US site.