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Compliance Supervisor Manufacturing

Employer
Regeneron
Location
Co. Limerick, Ireland
Salary
Competitive
Start date
29 May 2024
Closing date
17 Jun 2024

View more

Discipline
Manufacturing, Regulatory Affairs, Compliance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Within this role you will be responsible for the commercial manufacturing compliance requirements, supervising the compliance team in relation to completion of quality instances for the Manufacturing departments.

As a Supervisor in Manufacturing Compliance a typical day may include, but not limited to, the following:
  • Supervises the commercial scale manufacturing compliance aspect of recombinant proteins production to approved protocols, regulation, and schedule.
  • Supervises a team responsible for the delivery of the manufacturing compliance records in a cGMP regulatory environment.
  • Schedules team duties and tasks.
  • Ensures timely management of quality instance closure.
  • Authors manufacturing investigations.
  • Reviews, edits and approves compliance records in accordance with cGMP standards.
  • Coordinates and ensures quality system instances meet required timelines.
  • Recommends corrective actions based on investigational findings working cross functionally and cross site to reach agreement where needed.
  • Tracks quality system metrics including deviations, corrective actions and change controls.
  • Ensures audit readiness and coordinates where required.
  • Performs people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations.
  • Schedules individual and ongoing training.
  • Interfaces with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
  • Represents Manufacturing at all meetings as required.
  • Ensures that safety standards are maintained at all times.

This role might be for you if you:
  • Demonstrated skills in problem solving in a cross functional setting, with the ability to keep the team aligned to achieve meeting objectives.
  • Ability to work to tight timelines and knows when to escalate actions appropriately for resolution in a timely manner.
  • Prior technical writing experience within a manufacturing environment preferred.
  • Must have the ability to work in a fast paced environment, with the ability to manage multiple events for on-time closure.
  • Must be a highly proactive, detail-oriented individual who has the ability to adapt to change quickly.
  • Strong written and verbal communication skills are required.

To be considered for this role you will need a BS/BA in Life Sciences or related field with 5+ years of relevant cGMP manufacturing experience and some previous supervisory/leadership experience. Will substitute relevant experience in lieu of educational requirement.

#REGNIELSM #LI-Onsite #JOBSIEST

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.S.-based 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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