Staff GMP Data Governance Business Partner

The Staff GMP Data Governance Business Partner role implements the data governance standards, policies, and procedures into business operations. This position serves as a site resource and subject matter authority on good data governance and integrity (DGI) practices and ensures business groups are aligned to Regeneron Manufacturing's Data Governance Program.

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

• Implementation of standards, policies, and procedures and engage with the allocated business unit on DGI priorities, action plans.

• Assess business unit’s current policies and processes and be responsible for the achievement of local DGI significant metrics.

• Conduct regular data audits and assessments to identify DGI issues and work to prepare for DGI auditing and inspections.

• See opportunities to improve data-related processes, systems and tools within allocated business area that are aligned with the business’s evolving needs and industry standard processes.

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

• Feedback themes to Data Governance Leadership team to allow CI & evolution of the data governance approach.

This role might be for you if you:

• Stay updated on latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assessing the impact of these within Regeneron.

• Can foster a culture of quality & DGI within the organization.

• Encourage CI by actively seeking feedback and supporting initiatives designed to enhance data quality and governance.

• 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.

• Have expert knowledge of cGMP & GDP.

• Can translate complex regulatory and technical requirements into clear guidance for cross-functional teams.

• Possess strong stakeholder management and influencing skills.

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience for each level:

• Principal: 8+ years

• Staff: 10+ years

• Senior Staff: 12+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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