Principal GMP Data Governance Business Partner

In this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations. You will be a site resource and subject matter expert on good DG practices and ensure 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. 

In this role, a typical day might include the following:

• Implementation of standards, policies and procedures within allocated areas of the business 

• Be the allocated business area(s) key DG contact providing support and advice and engage with the allocated business unit on DG priorities and action plans 

• Assess allocated business unit’s current policies and processes and oversee the achievement of local DG KPIs 

• Conduct regular data audits and assessments to identify DG issues and work with business area to prepare for DG auditing and inspections  

• Work in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan and feedback themes to allow continuous improvement and evolution of the DG approach 

• Fostering a culture of quality and DG within the organisation and promoting the importance of DG across all departments    

• Driving communication and collaboration between stakeholders to ensure effective DG practices    

• Encouraging CI 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   

This role may be for you if you have:

• 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 

•   Experience in use of 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.   

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time of