Staff GMP Data Governance Business Partner at Regeneron Pharmaceuticals, Inc.

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 (DG) practices. This position ensures Business Groups are aligned to the IOPS Data Governance Program. This position supports the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program.

As a Staff GMP Data Governance Business Partner, a typical day might include the following:

• Implementation of standards, policies, and procedures and engage with the allocated business unit on DG priorities, action plans
• Assess business units current policies and processes and be responsible for the achievement of local DG significant metrics
• Conduct regular data audits and assessments to identify DG issues and work to prepare for DG auditing and inspections
• See opportunities to improve data-related processes, systems and tools within allocated business area that are aligned with the businesss evolving needs and industry standard processes
• Work in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan and feedback themes to allow CI & evolution of the DG approach
• Feedback themes to Data Governance Leadership team to allow CI & evolution of the data governance approach

This role might be for you if:

• Staying updated on latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assessing the impact of these within IOPS.
• Fostering a culture of quality & DG within the organisation.
• 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 companys core values and everyday practices.

To be considered for this role you must hold a Bachelors degree and

• Principal: 8+ years of professional experience
• Staff: 10+ years of professional experience
• Senior Staff: 12+ years of professional experience
• May consider experience in lieu of education in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT. Level decided upon completion of an interview process
• 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.
• Technical writing experience and an understanding of workflows & quality management technical writing terminology.
• The ability to collaborate with other SMEs, DG Business Partners, ECM Specialists and cross-functional teams with excellent communication skills.
• Knowledge of cGMP & GDP.
• Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.
• Strong stakeholder management and influencing skills

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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 off for eligible employees at all levels!

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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)