Principal GMP Data Governance Business Partner
1 day ago
In 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 resource and subject matter expert on good DG practices and ensure Business Groups are aligned to the IOPS Data Governance Program. Your remit will involve supporting the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program. In this role, a typical day might include the following: Implementation of standards, policies and procedures within allocated areas of the business Be 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 Assess allocated business unit's current policies and processes and oversee the achievement of local DG KPIs Conduct regular data audits and assessments to identify DG issues and work with business area to prepare for DG auditing and inspections Work in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan and feedback themes to allow continuous improvement and evolution of the DG approach Fostering a culture of quality and DG within the organisation and 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 This role may be for you if you 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 Demonstrated success in implementing and managing policies and standards within a regulated environment Excellent communication and collaboration skills Strong stakeholder management and influencing skills Experience in use of quality systems and/or 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. 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. 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.
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Principal GMP Data Governance Specialist
1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeThe Principal GMP Data Governance Specialist plays a pivotal part in ensuring that Regeneron's Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will beresponsible for providing specialised knowledge and expertise in the design of (DG) frameworks, policies and procedures that are aligned with...
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Director GMP Data Governance
1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeYour role is fundamental in ensuring Regeneron's data is effectively managed and utilised whilst remaining compliant with regulatory requirements. You will play a key role in fostering a data compliance culture and being accountable for developing comprehensive Data Governance (DG) policies and procedures across the organization. You will monitor the...
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Sr GMP Data Governance
1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeIn this role you will be responsible for fostering a culture of data governance (DG) within the site by ensuring compliance with Data Governance policies; designing and delivering relevant training; and monitoring Data Governance practices. The role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in...
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Limerick, Ireland Regeneron Ireland DAC Full timeIn this role you will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s). Your role will play a fundamental part in safeguarding the quality and reliability of the organisation's data which is essential for informed decision making and regulatory compliance. In this role, a...
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Limerick, Ireland Regeneron Ireland DAC Full timeThis leadership role is fundamental in creating, building & motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards. It offers an opportunity to shape the DG landscape of Regeneron, driving innovation and excellence through data. The role will suit a visionary leader with a passion for data and a track...
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Limerick, Ireland Regeneron Pharmaceuticals, Inc Full timeWithin this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...
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Limerick, Ireland Regeneron Ireland DAC Full timeWithin this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...
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Limerick, Ireland PM Group Full timeOverview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are seeking a skilled and motivated...
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Limerick, Ireland PM Group Full timeOverview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are seeking a skilled and motivated...
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Limerick, Ireland Reperio Human Capital (Ireland) Ltd Full timeLead Data Engineer Location: Limerick Salary: € Hybrid Reperio are working with a major fintech company who have major expansion plans for their Data team in Ireland in 2025. As part of these plans, they are seeking a Lead Data Engineer to be the driving force behind the design, development, and optimization of our data systems. You'll lead a team of...
