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Director GMP Compliance & Inspections

Employer
Regeneron
Location
Co. Limerick, Ireland
Salary
Competitive
Start date
1 Jun 2024
Closing date
30 Jun 2024

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

Job Details

Within this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing in a compliant manner. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes.

As Director of GMP Compliance & Inspections a typical day may include, but is not limited to, the following:
  • Utilizing strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems
  • Leading proactive evaluation and education of site GMP compliance against current and emerging regulatory trends
  • Defining and implementing systems, and metrics for maintaining regulatory compliance all operations
  • Performing evaluations of GMP compliance across all areas of the site as well as procedures and processes
  • Interfacing with customer/partner quality organizations
  • Participating on internal committees/teams, as required
  • Providing advice and direction to other departments on quality and regulatory issues

  • Benchmarking leading practices and recommending improvements to make IOPS inspection-ready at all times


  • Maintaining and organizing inspection readiness content, including building and maintaining a content repository, ensuring quick access to materials in the event of inspection or audit

  • Building and implementing tools improving IOPS inspection readiness
  • Identifying trends in recent regulatory inspections and translating this to recommendations to enhance readiness
  • Working closely with other regulatory compliance team to close gaps and improving inspection readiness capabilities
  • Liaising with regulatory bodies, and partners on audit, regulatory, and quality related matters. Providing guidance and advice to partners, and internal associates on regulatory and quality matters
  • Responding to incoming inquires during inspections and audits, ensuring timely and accurate audit response
  • Coordinating responses to regulatory or partner audits

To be considered for this opportunity you should hold a BA/BS degree in Life Sciences or related field and 12+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent combination of education and experience. Please note, this role could be considered at other levels depending on experience.

#IREADV #JOBSIEPR #LI-Onsite

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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