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. This individual will 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.This role will also promote and drive compliance by building inspection readiness processes across the organization.

As the Manager GMP Compliance & Inspections a typical day might include the following:

Ensuring readiness for regulatory inspections and partner/other audits in the creation, maintenance and management of inspection content, ensuring it is organized, current and readily accessible at all times

Planning all inspection and audit logistics and scenarios: communication plan, room allocations, backroom/frontroom configuration, technology checks & personnel assignments

Performing a lead role in the audit/inspection Backroom and responding to incoming requests 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

Coordinating inspection/audit responses and actively managing commitments to regulatory authorities/audit bodies in response to inspection/audit findings

Working collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirming their timely closure and ensuring suitable effectiveness checks are in place

Maintaining and enhancing communication processes to site management on the status of regulatory inspection readiness and CAPA commitments, including development of appropriate KPIs

Generating, developing and reporting metrics / trends for program adherence to requirements and effectiveness

Participating in proactive evaluation and education of site GMP compliance against current and emerging regulatory trends

Utilising strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems

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; determining system improvements through effective project management

Developing and delivering training on inspection conduct, backroom/frontroom protocols, and regulatory expectations

Working with department leaders and cross functional teams to educate, building and maintaining an inspection readiness structure across the organization

Liaising with partners on audit/inspection and quality related matters to provide guidance and advice

Participating on internal committees/teams, as required

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.

This role might be for you if:

You have strong project management, interpersonal, cross- cultural, communication, negotiation, and problem-solving skills
You understand and listen to team members and stakeholders while fostering a productive team environment to one common objective
You are driven for proactive resolution of issues with tact, diplomacy and composure
You show resiliency and flexibility in the face of challenges and adversarial situations
You are able to provide clear direction to others in ambiguous situations and environments
You possess knowledge of industry practices and regulations

To be considered for this role you should have a BA/BS degree in Life Sciences and the following:

Assoc Manager: 6+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent combination of education and experience.

Manager: 7+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent combination of education and experience.

#IRELIM #JOBSIEST #LI-Onsite

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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.

Manager GMP Compliance and Inspections

Benefits

Job Description