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Senior Specialist Global Auditing - Remote

Posted Yesterday

Overview

We are a research-driven biopharmaceutical company focused on delivering compliant, reliable supply to customers and patients through our Global Audit team.

In Short

  • Conduct audits of internal sites, contractors, and suppliers within EU/ME region.
  • Perform audit pre-work, conduct audits, and ensure post-audit activities are completed.
  • Partner with divisional oversight groups and commercial sites for audit preparation.
  • Maintain expertise in cGMP, company policies, and regulatory requirements.
  • Support new business opportunities through Due Diligence and Pre-Contract Audits.
  • Lead initiatives to improve the effectiveness and efficiency of the audit program.
  • Travel domestically and globally approximately 50% of the time.
  • Experience in auditing biologics, vaccine, and medical devices manufacturing sites preferred.
  • ASQ or IRCA Lead Auditor certification is a plus.
  • Engagement in regulatory or industry forums is advantageous.

Requirements

  • Bachelor's Degree in Science.
  • Experience in auditing within the pharmaceutical industry.
  • Strong compliance knowledge and regulatory interpretation skills.
  • Ability to work independently in a virtual-management environment.
  • Excellent communication and influencing skills.

Benefits

  • Opportunity to contribute to global medical advancements.
  • Work in a research-driven biopharmaceutical company.
  • Flexible work arrangements.
  • Join a team dedicated to high standards of quality.
  • Potential for professional development and certification.

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