Temp Compliance Specialist External Manufacturing

Regeneron Ireland
Employment Type
Not disclosed
Regeneron Ireland logo

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Working with our Drug Product team a typical day might include, but is not limited to, the following:

  • Lead and run deviation investigations, CAPAs, and change controls.
  • Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
  • Responsible for generating and supervising performance metrics.
  • Maintains knowledge of current good manufacturing practices cGMPs.
  • Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.
  • Maintain required training status on Regeneron specific work instructions and SOP’s.
  • Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.

This role might be for you if:

  • You enjoy working in a dynamic, fast-paced environment
  • You possess excellent interpersonal skills
  • You place a strong emphasis on attention to detail

To be considered for this opportunity you should have a BS/BA in a scientific discipline along with the years of related experience in a cGMP manufacturing operations (clinical and/or commercial drug products) outlined at the various levels below:

Associate Specialist: 0-2 years

Specialist: 2+ years

Senior Specialist: 5+ years

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, and fitness centers for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.