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Associate Director, GPS Quality and Compliance

Start date
13 Jun 2024
Closing date
12 Jul 2024

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Quality, QA / QC, Regulatory Affairs, Compliance
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Job Details

We are seeking an outstanding individual to lead our GPS Quality & Compliance team. This role is ideal for a resourceful and meticulous professional passionate about ensuring the highest standards in global patient safety. You will succeed in our multifaceted environment if you possess exceptional problem-solving skills, adaptability, and the ability to prioritize tasks. We hope you are excited about the opportunity to contribute the growth of our Quality and Compliance team.

As an Associate Director, GPS Quality and Compliance a typical day might include the following:
  • Developing and implementing compliance and quality oversight governance for GPS Safety Sciences deliverables, including Risk Management Plans, Signal Management, and the Pharmacovigilance System Master File.
  • Establishing and refining key performance indicators to ensure overall quality and compliance.
  • Collaborating closely with GPS subject matter experts, Regulatory Affairs, Medical Affairs, and other key functions to proactively identify potential trends or significant non-compliance.
  • Conducting non-compliance investigations for minor events, supporting investigation, and CAPA implementation of significant quality events.
  • Providing support for quality reviews of additional GPS deliverables, including Safety Agreements and Safety Management Plans.
  • Supporting GPS-related audits and inspections.

This role might be for you if:

  • Exceptional communication, interpersonal, and presentation skills with the ability to effectively interact with diverse collaborators.Proven track record to prioritize tasks effectively and manage multiple projects simultaneously.
  • You can work collaboratively across various functions and roles.
  • Possess a high level of accountability and consistently get results.
  • Demonstrate a strong understanding of global safety reporting regulations and guidelines, including FDA, ICH, and GVP.

To be considered for this opportunity, you must have a minimum of a Bachelor's Degree and 10 years of pharmacovigilance-related experience; a healthcare professional background is preferred. You should possess strong digital literacy, particularly with Microsoft programs (Word, Excel, PowerPoint, Outlook), and familiarity with data analytics platforms. A solid understanding of safety databases, medical concepts, and terminology is crucial. Expertise in benefit-risk management and experience in leading job performance. We need someone who will demonstrate success in leading and implementing quality and compliance programs within a global pharmaceutical environment.

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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