Associate Director – Inspection Management – Limerick Full Time

Purpose:

The individual will provide support during regulatory inspections and internal audits. This individual will also work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. Additionally, the individual will work with department leaders to build an inspection readiness capability across the organization.

Responsibilities:

• 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:
  • Liaison with regulatory bodies, partners and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to partners, suppliers and internal associates on regulatory and quality matters.
  • Respond to incoming inquires during inspections and audits and ensure timely and accurate responses.
• Ensure marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU.
• Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for clinical and commercial operations.
• Interfaces with customer/partner quality organizations.
• Participates on internal committees/teams, as required.
• Provides advice and direction to other company departments on quality and regulatory issues.

Minimum Qualifications and Experience:

• Requires BA/BS degree in in chemical engineering/chemistry/life sciences.
• Process engineering or validation background & experience desired.
• 8-10+ years of relevant experience in a biotech or pharmaceutical environment.