The Manager GMP Compliance & Inspections will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS.
This role will also promote and drive compliance by building inspection readiness processes across the organization.
This individual will also play a leading role in the preparation and execution of regulatory inspections, partner audits and internal audits, as well as follow up post audit/inspection on any items requiring response and action.
A typical day might include, but is not limited to, the following: Working with department leaders and cross functional teams to educate, build and maintain an inspection readiness structure across the organization Leading proactive evaluation and education of site GMP compliance against current and emerging regulatory trends Supporting regulatory inspections and partner audits in creating, maintaining and managing inspection content, ensuring it is organized, current and readily accessible at all times Responding to incoming enquiries during inspections and audits and ensuring timely and accurate responses Evaluating outcomes of regulatory authority inspections/partner and other audits to identify near misses, lessons learned and other best practices and working cross-functionally to ensure identified process or system improvement opportunities are sustainably implemented Establishing and maintaining a communication process mechanism to site management on the status of regulatory inspection readiness and CAPA commitments Evaluating and managing proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings Work collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirm their timely closure and ensure suitable effectiveness checks are in place Generating, developing and reporting metrics / trends for program adherence to requirements and effectiveness Supporting and leading teams implementing practices and improvements to make IOPS inspection-ready at all times Building and implementing tools to improve IOPS inspection readiness; determine system improvements through effective project management Participating on internal committees/teams, as required Providing advice and direction to company departments on quality and regulatory issues Cross-site support of inspection readiness and inspection activities Coordinating Regeneron information to support regulatory requests for paper inspections and/or observation responses Additional duties may be assigned as required To be considered for this opportunity you should have a BA/BS degree in Life Sciences and 7+ 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.
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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.
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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. 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.