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.

Inspection Readiness:

• 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.

Inspection Execution:

• 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.
  
  
  

• To be considered for this opportunity you should hold a BA/BS degree in Life Sciences or related field and 10+ 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.