Job Description
In this role, you will be responsible for implementing data governance standards, policies, and procedures into business operations.
You will be a site resource and subject matter expert on good data governance practices, ensuring Business Groups are aligned to the IOPS Data Governance Program.
Your remit will involve supporting the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program.
Key Responsibilities:
* Implementation of standards, policies, and procedures within allocated areas of the business
* Be the allocated business area(s) key data governance contact, providing support and advice, and engaging with the allocated business unit on data governance priorities and action plans
* Assess allocated business units' current policies and processes and oversee the achievement of local data governance KPIs
* Conduct regular data audits and assessments to identify data governance issues and work with business areas to prepare for data governance auditing and inspections
* Work in partnership with other data governance business partners, technical data governance experts, and ECM experts to deliver on the data governance plan and provide feedback to allow continuous improvement and evolution of the data governance approach
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
* Demonstrated success in implementing and managing policies and standards within a regulated environment
* Excellent communication and collaboration skills
* Strong stakeholder management and influencing skills
* Experience in using quality systems and/or change management
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.