At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Senior Quality Compliance Specialist to join our Quality Assurance Compliance & Quality Systems team.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
- Location: Raheen, Limerick.
- Ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
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Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
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Collaborating with Cross functional teams to resolve issues, complete investigations and maintain compliance.
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Assessing and approving Failure investigations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP’s), GxP documents and Change control documents.
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Leading and supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver.
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Evaluating procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
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Monitoring and trending metrics associated with site quality systems.
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Actively participating in continuous improvement ideas, initiation, and implementation.
- Proven experience in conducting on-site investigations and analysis.
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Able to prioritise, re-prioritise as needed and adapt to change.
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Comfortable working in a fast-paced setting.
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Relationship builder with customers and internal key stakeholders.
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Comfortable in ambiguous environment and ability to translate ambiguity into actionable steps.
- Specialist - BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience.
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Sr Specialist - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
€54,200.00 - €88,400.00
