Staff GMP Data Governance Business Partner

Regeneron Pharmaceuticals

1d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree (or proven experience may substitute for education requirement).
• 10+ years of relevant experience.
• 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.
• Expert 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.

Nice To Haves

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

Responsibilities

• Implement data governance standards, policies, and procedures into business operations.
• Serve as a site resource and subject matter authority on good data governance and integrity (DGI) practices.
• Ensure business groups are aligned to Regeneron Manufacturing's Data Governance Program.
• Engage with the allocated business unit on DGI priorities and action plans.
• Assess business unit’s current policies and processes.
• Be responsible for the achievement of local DGI significant metrics.
• Conduct regular data audits and assessments to identify DGI issues.
• Prepare for DGI auditing and inspections.
• Identify opportunities to improve data-related processes, systems, and tools within the allocated business area.
• Work in partnership with other DGI Business Partners, Technical Experts & ECM Experts to deliver on the plan.
• Provide feedback themes to allow for continuous improvement (CI) and evolution of the DGI approach.
• Provide feedback themes to the Data Governance Leadership team to allow for CI and evolution of the data governance approach.

Benefits

• 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
• Paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees