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Regeneron Ireland

Senior Compliance Specialist

Regeneron Ireland

  • Limerick
  • See description
  • Permanent full-time
  • Updated 07/10/2017
  • Regeneron Pharmaceuticals
this job is expired
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Summary: The position coordinates cGMP compliance for the Raheen Facilities Department.


Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.

Essential Duties and Responsibilities include, but are not limited to, the following:
* Supervisory role responsible for the coordination of cGMP compliance with all aspects of Quality for the Facilities Department.
* Lead and manage deviation investigations, CAPAs, Change Control, Audits, and Quality Risk Management for Facilities Department issues of non-compliance.
* Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
* Provides support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as Change Controls, Deviations, impact statements and corrective action plans.
* Responsible for generating and tracking Quality compliance metrics.
* Participates in in internal, regulatory and customer audits.
* Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance.
* Maintains knowledge of current good manufacturing practices cGMPs.
* Responsible for periodic reviews of Facilities Department documentation and records such as logbooks, preventative maintenance records and work orders to assess for compliance with established quality standards, policies and procedures.

Education and Experience:
* BS/BA in engineering or scientific related field with 5+ years of related professional experience in a cGMP environment or in the operation of an industrial facility.
* Minimum of 3+ years experience working in a Compliance function in a cGMP environment.
* Ability to work on own initiative, without direct supervision from management.
* Team player with an ability to work well across various departments on site as well as business partners.
* Excellent written, presentation, communication and investigation skills.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.

To apply for this position please click here

Ref: 10706BR_1506004412
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Regeneron Ireland

Regeneron Ireland

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