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 (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 unit’s 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 the allocated business area that are aligned with the business’s 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 company’s core values and everyday practices.To be considered for this role you must hold a Bachelor’s degree and:Principal: 8+ years of professional experience.Staff: 10+ 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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