Senior Audit And Compliance Specialist

Abbott

Galway, Ireland
Base: not specified; bonus/equity: not specified; ...
Hybrid
5 years regulated manufacturing experience
Mdsap mdr ivdr cgmp knowledge
Independent supplier audit leadership
Abbott is seeking a Senior Audit and Compliance Specialist in Galway, Ireland, to oversee supplier audits and ensure compliance with regulatory standards within the Infectious Disease Business Unit. The ideal candidate will have significant experience in a regulated manufacturing environment, with strong skills in quality assurance and regulatory compliance

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 other applicable regulatory requirements.
  • The incumbent will independently conduct audits, coordinate external inspections, and support sites in implementing quality system improvements and resolving aged CAPAs.

Matching Summary

Match Score: 85

Abbott is seeking a Senior Audit and Compliance Specialist in Galway, Ireland, to oversee supplier audits and ensure compliance with regulatory standards within the Infectious Disease Business Unit. The ideal candidate will have significant experience in a regulated manufacturing environment, with strong skills in quality assurance and regulatory compliance.

Salary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Ability to travel 40-50% of time
  • Strong organizational and communication skills
  • Critical thinking for aged CAPA resolution
  • Experience with complaint investigations
  • Proficiency in Word Excel PowerPoint Outlook

Key Requirements

  • Bachelor's degree in life science or engineering
  • Minimum 5 years in regulated manufacturing environment
  • Experience leading independent supplier audits
  • Knowledge of MDSAP and MDR/IVDR regulations

Work Rights

Not specified

Tailored Resume

Cover Letter