Site Quality Manager

3 days ago


North Yorkshire, United Kingdom Consult Full time
Site Quality Director Opportunity

We are seeking a highly experienced Site Quality Director to oversee our manufacturing facility in North Yorkshire.

Key Responsibilities:
  • Manage the Quality teams and ensure compliance with UK, EU, and FDA cGMP standards.
  • Develop and implement a sustainable quality strategy for the site, aligned with the company's strategic goals.
  • Drive performance improvements and ensure compliance with regulatory requirements.
  • Coordinate with regulatory authorities and stakeholders.
  • Mentor and develop the quality team to improve their knowledge and skills.
  • Support the implementation of new initiatives and systems.
  • Troubleshoot and contribute to manufacturing and testing issues.
  • Report on changes in standards and performance.
  • Host regulatory and customer audits.
  • Liaise with the multi-site Quality Director to ensure consistency across manufacturing sites.
Requirements:
  • Extensive experience in pharmaceutical quality, including audit, batch record review, change control, complaint handling, and investigations.
  • A thorough understanding of pharmaceutical manufacturing, packaging, testing, and distribution processes, as well as global regulatory requirements.
  • Experience with UK and FDA inspections, client audits, and self-inspections.
  • Proven track record of implementing and maintaining quality systems.
  • Technical knowledge to support quality and validation decision making.
  • Experience working on multi-department projects.

Occasional global travel may be required.



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