Job Description
Within this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing in a compliant manner. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes.As Director of GMP Compliance & Inspections a typical day may include, but is not limited to, the following:Utilizing strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problemsLeading proactive evaluation and education of site GMP compliance against current and emerging regulatory trendsDefining and implementing systems, and metrics for maintaining regulatory compliance all operationsPerforming evaluations of GMP compliance across all areas of the site as well as procedures and processesInterfacing with customer/partner quality organizationsParticipating on internal committees/teams as requiredProviding advice and direction to other departments on quality and regulatory issuesBenchmarking leading practices and recommending improvements to make IOPS inspection-ready at all timesMaintaining and organizing inspection readiness content, including building and maintaining a content repository, ensuring quick access to materials in the event of inspection or auditBuilding and implementing tools improving IOPS inspection readinessIdentifying trends in recent regulatory inspections and translating this to recommendations to enhance readinessWorking closely with other regulatory compliance teams to close gaps and improving inspection readiness capabilitiesLiaising with regulatory bodies and partners on audit, regulatory, and quality related matters; Providing guidance and advice to partners, and internal associates on regulatory and quality mattersResponding to incoming inquiries during inspections and audits, ensuring timely and accurate audit responseCoordinating responses to regulatory or partner auditsTo be considered for this opportunity you should hold a BA/BS degree in Life Sciences or related field and 12+ 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