Job Description
In this role, you will be responsible for implementing data governance standards, policies, and procedures into business operations.
Key Responsibilities
* Support the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program.
* Implement standards, policies, and procedures within allocated areas of the business.
* Provide support and advice to Business Groups as a subject matter expert on good DG practices.
* Assess allocated business units' current policies and processes and oversee the achievement of local DG KPIs.
* Conduct regular data audits and assessments to identify DG issues.
* Work in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan.
* Foster a culture of quality and DG within the organization and promote the importance of DG across all departments.
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.
* Demonstrated success in implementing and managing policies and standards within a regulated environment.
* Excellent communication and collaboration skills.
* Strong stakeholder management and influencing skills.
Education and Experience
To be considered for this role, you must hold a BA/BS degree and 7+ years of professional experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.