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Principal Gmp Data Governance Business Partner

3 weeks ago

Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

Within this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations.
You will be a site expert on Data Governance, supporting the Regeneron IOPS Data Governance and Integrity program.
In this role, a typical day might include the following: Implementing the Data Governance standards, policies and procedures within allocated areas of the business Being the allocated business area(s) key DG contact providing support and advice and engage with the allocated business unit on DG priorities and action plans Assessing allocated business unit's current policies and processes and coordinate the achievement of local KPIs Conducting regular data audits and assessments to identify DG issues and work with business area to prepare for DG auditing and inspections Working with DG Business Partners, Technical Experts, and ECM Experts to deliver the DG plan and provide feedback for continuous improvement Encouraging a culture of quality and Data Governance within the organisation and promoting the importance of DG across all departments Driving communication and collaboration between stakeholders to ensure effective DG practices Encouraging continuous improvement by actively seeking feedback and supporting initiatives designed to improve data quality and governance Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices This role may be for you if: You have knowledge of relevant regulations and guidelines (e.g., GDPR, FDA, EMA, WHO) You have proven success in implementing and managing policies in regulated environments You bring strong communication and collaboration skills You are skilled in stakeholder management and influence You have experience with quality systems and change management To be considered for this role you must hold a BA/BS degree and 7+ years of professional experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.
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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.