Associate Director Qualified Person
2 days ago
Within this role you will be responsible for providing expertise and leadership in the quality function. You will be responsible to ensure that licensed product is certified and released to market in compliance with commercial manufacturing license and clinical (IMP) products. As an Associate Director Qualified Person a typical day might include, but is not limited to, the following: Owning and continuously improving the batch disposition of quality in the Industrial Operations and Product Supply organization Being responsible for disposition of medicinal product Interacting with critical biotechnology commercial and clinical API and fill/finish manufacturing operations, facilities and quality control laboratories to ensure a successful compliance profile Partnering with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfacing with customer/partner quality organizations, and negotiating third party contractor and supplier quality agreements Coordinating QA resources assigned to functional area to meet goals and timings; prioritization of activities with area management Participating in cross functional teams as Quality/Qualified Person representative Providing advice and direction to other company departments on quality and regulatory issues Acting as an auditor on behalf of Regeneron Ireland Involved in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensuring regulatory observations are adequately addresses and completed on schedule Authorising significant deviations to established, approved procedures, provides mentorship to assist co-workers with troubleshooting investigations and problem resolution Ensuring safety and operational standards are maintained This role might be for you if: You have 5 years work experience acting as Qualified Person, named on the Manufacturing and Importation Authorisation (MIA) license You have expert knowledge of 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use You have the ability to research, analyze and extrapolate critical regulatory information You are team-oriented and a positive relationship builder You have an ability to optimally collaborate with a range of individuals across the organization at all levels To be considered for this opportunity you should have a third level qualification (degree in science or related discipline preferred) appropriate for QP eligibility and a minimum of 8 years of related experience in the pharmaceutical and/or biotechnology industry. #REGNIEQA #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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Associate Director, Talent Brand
15 hours ago
Limerick, Ireland Regeneron Ireland DAC Full timeWe are seeking an expert in employer/talent brand with significant experience in digital recruitment marketing channels, ideally with on-the-ground experience in multiple international markets. The Associate Director, Talent Brand role has overall responsibility for the development and curation of Regeneron's global talent brand, across all "bought" "owned"...
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Senior Tax Manager or Tax Director
1 day ago
Limerick, Ireland Martina Quinn Finance Recruitment Full timeMeet your potential employer? Would you consider relocating to advance your career? An opportunity has opened for a Senior Tax Manager, Associate Tax Director or Tax Director to join one of the Top 10 firms in Limerick, a city renowned for its academic excellence, innovative spirit, and quality of life. You will be working for a forward-looking firm that...
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Director/Senior Director EHS
2 days ago
Limerick, Ireland Regeneron Ireland DAC Full timeThe Director/Sr Director EHS & Security will be responsible for the oversight of all Health, Safety, Environmental and Security operations to comply with or exceed local and national environmental regulatory compliance for IOPS (Industrial Operations & Product Supply) division of Regeneron in Limerick. As the Director/Sr Director EHS & Security, a typical...
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Associate Director of Program Management
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Limerick, Ireland BD Medical Full timeJob Description Summary We are the makers of possible! BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to...
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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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Tax Director
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Limerick, Ireland Mazars Chartered Accountants Full timeForvis Mazars, the smart choice Forvis Mazars in Ireland is a leading professional services firm with ambitious growth plans and over 800 staff based in Dublin, Galway and Limerick. We are an integral part of Forvis Mazars Group, an internationally integrated partnership with over 50,000 professionals operating in over 100 countries and territories around...
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Associate Biotech Production Specialist
2 days ago
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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Executive Director GMP Data Governance
2 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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Person In Charge
1 day ago
Limerick, Ireland Nua Healthcare Full timeNua Healthcare Services (Nua) is one of Irelands leading Private Healthcare Providers, specialising in Residential and Supported Living Services, to both Children and Adults with a range of complex support needs. We support people in reaching their full potential, to have a meaningful life through the supports of the services we provide to them. We are...
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Associate Manager Quality Compliance
2 days ago
Limerick, Ireland Regeneron Ireland DAC Full timeThis is a leadership role providing Quality and Compliance oversight of site operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Associate Manager Quality...
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Nua Healthcare | Person In Charge
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Limerick, Ireland Nua Healthcare Full timeNua Healthcare Services (Nua) is one of Irelands leading Private Healthcare Providers, specialising in Residential and Supported Living Services, to both Children and Adults with a range of complex support needs. We support people in reaching their full potential, to have a meaningful life through the supports of the services we provide to them. We are...
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Limerick, Ireland Regeneron Ireland DAC Full timeWithin this role you will be primarily responsible for all aspects of calibration of instruments & equipment across the entire site, including compliance and management of contracts and projects. You will be responsible for day-to-day operations of the Calibration team, staff leadership and resource management. As an Associate Manager/Manager in Calibration...
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Cook Medical | Director, Engineering
3 weeks ago
Limerick, Ireland Cook Medical Full timeOverview The primary function of this role is to provide leadership and direction to the Post Market and Manufacturing Engineering teams, while taking overall responsibility for effective and efficient running of the department. The Director, Engineering is also responsible for working with Local and Global Functional Leaders, and Divisions to manage all...
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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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Director GMP Data Governance
2 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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Project Manager 1, Regulatory Affairs
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Limerick, Ireland Cook Ireland Ltd Full timeOverview The primary role of the Project Manager 1 is to provide support for the daily activities associated with global regulatory projects, including communicating with the various teams on regulatory projects. Reporting to: Director, Regulatory Affairs Responsibilities Establish project plans with associated milestones and deadlines. Communicate with...
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Director GMP Data Governance
2 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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Financial Accountant
15 hours ago
Limerick, Ireland Martina Quinn Finance Recruitment Full timeMeet your potential employer? Martina Quinn Finance Recruitment is proud to partner with a globally recognized multinational company in their search for a Financial Accountant to join their finance team based in Limerick. This is a fantastic opportunity to enhance your finance career within an organisation that values innovation, collaboration, and...
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Supply Compliance Senior
2 days ago
Limerick, Ireland Regeneron Ireland DAC Full timeWithin this role you will be responsible for initiating, leading and executing compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within Supply Chain Management. As a Supply Compliance Senior / Analyst, a typical day might include, but is not limited to, the following: Developing an effective compliance...
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Financial Accountant
15 hours ago
Limerick, Ireland Nexus Recruitment Partners Full timeOur client is a leading Global Professional Services firm in Ireland with ambitious growth plans and over 600 staff based in Dublin, Galway, Limerick and Cork and over 50,000 employees worldwide. The Firm is now continuing to expand its Financial Accounting & Outsourcing Services and are recruiting a Qualified Accountants to join the team. The clients range...
