Regional Compliance Auditor

Posted 22 April 2022
SalaryUp to £0.00 per annum
Job type Contract
DisciplineLife Sciences & Engineering Technologies
ContactAnita Osibuamhe

Job description

A globally leading biopharmaceutical company are seeking a Regional Compliance Auditor to join them on an initial 7 month contract basis. This position offers a competitive day rate and remote working options.


  • The Regional Compliance Auditor will conduct on-site audits of the organisation's manufacturing sites and its suppliers - with the goal of determining compliance gaps and necessary remediation plans. The auditor will promptly deliver/communicate audit findings using predetermined processes and methodology.
  • Stewardship of the auditing processes for the business
  • The Regional compliance auditor (RCA) will Plan audit program for the region


  • Plan audit program for the region with sites and centre functions for internal sites, suppliers, and contractors. Through the coordination of the Risk assessment process
  • Ensure that the site auditors in the region are developed and trained.
  • Interface with Quality Platform Leaders on GQCA audit activities and issues identified during GQCA audits.
  • Review and approve audit reports.
  • Conducting quality audits of global and regional Global Manufacturing and Supply Sites (GMS), Suppliers and Contractors
  • Conduct Mock PAI and inspection readiness assessments at GMS Sites and contractors
  • Follow up and tracking of CAPA completion
  • Train sites and center colleagues on conducting audits (auditor qualification) and other points of compliance as a global SME. Act as a coach and trainer for regional and site auditors
  • Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment the business' quality assurance programs.
  • Stewardship of the auditing processes for the business by ensuring that the global audit processes are fit for purpose and aligned to business needs
  • Act as an auditing SME and coach and support on site auditors as needed and assigned
  • Quality Culture ambassador


  • Science or Engineering Bachelors / Masters Degree (Microbiology or Immunology Preferred)
  • Significant Operations and/or Quality experience (5+ years) in Animal Health/Human Health manufacturing
  • Experience as an FDA/USDA or Similar Regulatory Agency Inspector
  • Sterile Manufacturing/Biologics/Vaccine experience
  • Medical device and or diagnostics experience is a distinct advantage
  • Demonstrated ability to operate successfully in a matrix organization
  • Six Sigma Black Belt / Green Belt or Lean Practioner Preferred
  • Experience in working with FDA, EU, USDA, Russian, Turkish, and Chinese regulations.


  • Demonstrated knowledge in a Quality Operations Role
  • Fluent with compliance regulators
  • Excellent communication skills (written, oral, and listening)
  • Demonstrated independent contributor
  • Deep expertise in planning, organizing, and follow up methodology; punctual

To learn more, Apply now or contact Anita with your CV at anita.osibuamhe@hrmrecruit to set up a confidential call