Manager GMP Compliance and Inspections

We are seeking a Manager for GMP Compliance & Inspections who 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 minimum years of relevant experience for each level:

• 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. 

Level will be determined based on qualifications and experience relevant to the role.

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