Job Description
The Manager/Senior 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 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 organizationLeading proactive evaluation and education of site GMP compliance against current and emerging regulatory trendsSupporting regulatory inspections and partner audits in creating, maintaining and managing inspection content, ensuring it is organized, current and readily accessible at all timesResponding to incoming enquiries during inspections and audits and ensuring timely and accurate responsesEvaluating 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 implementedEstablishing and maintaining a communication process mechanism to site management on the status of regulatory inspection readiness and CAPA commitmentsEvaluating and managing proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findingsWork 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 placeGenerating, developing and reporting metrics / trends for program adherence to requirements and effectivenessSupporting and leading teams implementing practices and improvements to make the site inspection-ready at all timesBuilding and implementing tools to improve inspection readiness; determine system improvements through effective project managementParticipating on internal committees/teams, as requiredProviding advice and direction to company departments on quality and regulatory issuesCross-site support of inspection readiness and inspection activitiesCoordinating Regeneron information to support regulatory requests for paper inspections and/or observation responsesAdditional duties may be assigned as requiredTo 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. #J-18808-Ljbffr