Staff GMP Data Integrity Business Partner

The Staff GMP Data Integrity 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 are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$92,200.00 - $206,100.00