Director, Quality and Risk Management
2 days ago
Site Quality Director Competitive package including bonus and a number of benefits
Our client, a leading global specialist in pharmaceuticals, committed to delivering high-quality products are known for their expertise in various areas, including endocrinology, dermatology, analgesia, and pain management.
They are now seeking a highly experienced Site Quality Director to oversee their manufacturing facility in North Yorkshire.
As Site Quality Director, you will be responsible for managing the Quality teams, ensuring compliance with UK, EU, and FDA cGMP standards, and driving continuous quality improvement.
Provide strong leadership to the quality team, fostering a positive and collaborative work environment.
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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