Principal GMP Data Governance Specialist
3 days ago
The 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 regulatory requirements and industry standards. In this role, a typical day might include the following: Assessing current and evolving regulatory guidance and industrial intelligence in relation to IOPS business practices Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices Technical writing, research and related editing activities, ensuring accuracy and consistency of documentation and that the appropriate approvals are received Generating and performing data mapping processes, risk assessments of all GMP documentation and criticality assessments Identifying potential data governance and integrity gaps and proposing solutions with an implementation plan. Leading data integrity (DI) remediation activities as per the DI Quality Plan Providing expertise and support during the development of new systems and processes Fostering a culture of quality & 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 continuous improvement 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 Technical writing experience and an understanding of workflows and 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 Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams Strong stakeholder management and influencing skills Experience of developing global policies, procedures and standards both with and through the business 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. #JOBSIEPR 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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Limerick, Ireland Regeneron Ireland DAC Full timeIn 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...
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Director GMP Data Governance
3 days ago
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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Director GMP Data Governance
3 days 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 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...
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Executive Director GMP Data Governance
3 days ago
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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Principal QA Validation Specialist
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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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Principal Quality Systems Specialist
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Limerick, Ireland CareerWise Recruitment Full timeSenior Principal Bioprocess Scientist required manufactring client in Limerick. The Senior Principal Bioprocess Scientist will be responsible for providing technical support to introduce and sustain advanced upstream cell culture manufacturing processes at the next-generation bioprocessing site at Limerick. Responsibilities: Have an in-depth knowledge of the...
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Limerick, Ireland Life Science Recruitment Ltd Full timeSenior Principal Upstream Bioprocess Scientist Our client, a global pharma company with a state-of-the-art biotech manufacturing facility in Limerick, are currently recruiting for a Senior Principal Upstream Bioprocess Scientist to join their team on a permanent basis. As Senior Principal Upstream Bioprocess Scientist you will be responsible for providing...
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Change Management Specialist
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Limerick, Ireland Northern Trust Full timeAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
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Associate Biotech Production Specialist
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Limerick, Ireland Regeneron Ireland DAC Full timeWithin this role you will be working as part of the Manufacturing Team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors. As an Associate Biotech Production Specialist, a typical shift might include, but is not limited to, the following: Working as part of the Manufacturing team to carry out tasks in line with...
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Clinical Support Specialist
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Limerick, Ireland BMS Recruitment Full timeExcellent field-based training role for a qualified healthcare professional Training and support role working within Community Nursing, Care Homes, and Hospitals. Privately-owned company with excellent products and service Emphasis on strong teamwork and collaboration THE COMPANY: They provide a well-respected, quality range of products that are used for a...
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Temp Senior QC Specialist
1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeThe successful candidate will manage and support the external testing activities within the Quality Control group in support of the company's quality program. A typical day might include, but is not limited to, the following: Organizing and scheduling external testing to support product release/stability testing under cGMP Managing external data review per...
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Northern Trust | Change Management Specialist
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Limerick, Ireland Northern Trust Full timeAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
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Limerick, Ireland Greg O'Hanlon International Ltd Full timeCompany:Our client is an Irish, family-owned fresh food company established more than 30 years ago who specialise in both traded and value-add fresh food products. They have a number of locations around Munster employing over 60 people with a turnover of approximately €50 mil. They are a premium end of the market food business leading the way in terms of...
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Sr QA Validation Specialist
1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeThe individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory...
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Global Procurement Specialist
1 day ago
Limerick, Ireland Regeneron Ireland DAC Full timeThe Global Procurement Specialist will be responsible for supporting and assisting the Category Management strategy by gathering and anticipating business unit supply needs and specifications for the Raw Materials / Direct Materials category. A typical day might include, but is not limited to the following: Supporting the Category Manager with the category...
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Limerick, Ireland Milford Care Centre Full timeMilford Care Centre, Limerick Serving the people of the Mid-West Milford Care Centre is a Section 38 organisation, working in partnership with the HSE Mid-West, and provides a comprehensive range of Specialist Palliative Care Services and Services for Older People across Counties Clare, Limerick, and North Tipperary. WE ARE INVITING APPLICATIONS FOR THE...
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Specialist, Global Procurement
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Limerick, Ireland Regeneron Ireland DAC Full timeThe Global Procurement, Supplier Quality Compliance Specialist will be responsible for supporting cGMP compliance aspects of Regeneron's procurement operations. The major activities include but are not limited to the following: working with team members and our Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and...
