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.

POSITION SUMMARY

• 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

POSITION RESPONSIBILITIES

• 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

EDUCATION AND EXPERIENCE

• 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.

TECHNICAL SKILLS REQUIREMENTS

• 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