Director GMP Compliance & Inspections
Job details
The Associate Director of GMP Compliance & Inspections will work 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 Associate 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 Associate Director of GMP Compliance & Inspections a typical day may include: Compliance:
- Utilise strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems.
- Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.
- Define and implement systems, and metrics for maintaining regulatory compliance all operations.
- Perform evaluations of GMP compliance across all areas of the site as well as procedures and processes.
- Interface with customer/partner quality organizations.
- Participate on internal committees/teams, as required.
- Provide advice and direction to other departments on quality and regulatory issues.
- Benchmark leading practices and recommend improvements to make IOPS inspection-ready at all times.
- Maintain and organize inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit.
- Build and implement tools to improve IOPS inspection readiness.
- Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness.
- Work closely with other regulatory compliance team to close gaps and improve inspection readiness capabilities.
- Liaise with regulatory bodies, and partners on audit, regulatory, and quality related matters. Will also provide guidance and advice to partners, and internal associates on regulatory and quality matters.
- Respond to incoming inquires during inspections and audits and ensure timely and accurate during audit response.
- Coordination of responses to regulatory or partner audits.
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