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 problems
* Leading proactive evaluation and education of site GMP compliance against current and emerging regulatory trends
* Defining and implementing systems, and metrics for maintaining regulatory compliance all operations
* Performing evaluations of GMP compliance across all areas of the site as well as procedures and processes
* Interfacing with customer/partner quality organizations
* Participating on internal committees/teams as required
* Providing advice and direction to other departments on quality and regulatory issues
* Benchmarking leading practices and recommending improvements to make IOPS inspection-ready at all times
* Maintaining and organizing inspection readiness content, including building and maintaining a content repository, ensuring quick access to materials in the event of inspection or audit
* Building and implementing tools improving IOPS inspection readiness
* Identifying trends in recent regulatory inspections and translating this to recommendations to enhance readiness
* Working closely with other regulatory compliance teams to close gaps and improving inspection readiness capabilities
* Liaising 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 matters
* Responding to incoming inquiries during inspections and audits, ensuring timely and accurate audit response
* Coordinating responses to regulatory or partner audits
To 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.
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