Site Quality Manager
3 days ago
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.
- 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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