Senior Audit And Compliance Specialist

Abbott

Galway, Ireland
Base: not specified; bonus/equity: not specified; ...
Not specified; likely hybrid based on industry norms and responsibilities.
5 years regulated manufacturing experience
Independent supplier audit leadership
Mdsap and mdr/ivdr regulatory knowledge
Abbott is seeking a Senior Audit and Compliance Specialist for their Infectious Disease Business Unit in Galway, Ireland. The role involves conducting supplier audits, ensuring compliance with regulatory standards, and maintaining inspection readiness within the division

Job Summary

  • The Senior Audit & Compliance Specialist will uphold the supplier audit program and lead audits for sites in the RMDx Division within the Infectious Disease Business Unit.
  • This role is critical for maintaining continuous inspection readiness and ensuring compliance with MDSAP, MDR/IVDR, and cGMP regulations across global sites.
  • The position requires supporting external inspections, coordinating logistics, coaching auditees, and driving quality system improvement initiatives.

Matching Summary

Match Score: 85

Abbott is seeking a Senior Audit and Compliance Specialist for their Infectious Disease Business Unit in Galway, Ireland. The role involves conducting supplier audits, ensuring compliance with regulatory standards, and maintaining inspection readiness within the division.

Salary

Base: Not specified; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 5 years regulated manufacturing experience
  • Independent supplier audit leadership
  • MDSAP and MDR/IVDR regulatory knowledge
  • External inspection support and logistics
  • Technical documentation review for compliance

Nice-to-have

  • Critical thinking for aged CAPA resolution
  • Strong organizational and communication skills
  • Ability to work independently in fast pace
  • Willingness to travel 40-50% of time

Key Requirements

  • Bachelor's degree in life science or engineering
  • Minimum 5 years in regulated manufacturing environment
  • Experience with MDSAP, MDR/IVDR, and cGMP
  • Proven track record of independent supplier audits

Work Rights

Not specified

Tailored Resume

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