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Associate Director, GPS Inspections and Audits

Employer
Regeneron
Location
Dublin, Ireland
Salary
Competitive
Start date
10 Jun 2024
Closing date
19 Jun 2024

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Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

This position is responsible for supporting the quality & compliance activities associated with Global Patient Safety. Such activities include, but are not limited to, ensuring GPS inspection readiness, leading GPS facilitation for all GPS-impacted audits and inspections, and supporting the development and implementation of corrective actions and preventative actions.
  • Benchmark leading practices to develop an inspection readiness model for Global Patient Safety.
  • Maintain inspection and audit readiness for GPS, including building and maintaining a content repository to support inspections and audits.
  • Build and implement tools to improve GPS Inspection Readiness.
  • Identify trends in recent regulatory inspections and develop implementation plans for continued inspection readiness and process improvements.
  • Lead proactive evaluation and education of GPS compliance against current and emerging regulatory trends.
  • Liaise with GPS subject matter experts, Regulatory Affairs, Medical Affairs, and other key functions as related to GPS inspection readiness and proactively identify potential trends or significant non-compliance.
  • Point-of-contact for GPS related audits and inspections, working closely with GD Quality and Inspection Management to facilitate preparation, execution, and follow-up on all GPS-impacted audits and inspections.
  • Coordinate GPS responses to inspection and audits.
  • Conduct Global Patient Safety-related non-compliance investigations for minor events including trending and support investigation and CAPA implementation of any significant quality events as needed.
  • Provide support for quality and compliance of additional GPS deliverables including updating the PSMF as related to GPS Quality & Compliance deliverables.
  • Assist in review and contribution to Global Patient Safety Quality and Compliance-related documented procedures.
  • Effectively manage workload to independently ensure overall compliance with standards and timelines.
  • Work effectively with other Global Patient Safety sub-functions, Contract Research Organization, Vendors, and relevant personnel to discuss issues and identify timely solutions.
  • Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly.

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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