Site Quality Director

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.
• Manage departmental activities and resources within budget and timelines.
• 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.
• Establish effective communication strategies.
• 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.

• Significant leadership experience
• Extensive experience in pharmaceutical quality, including audit, batch record review, change control, complaint handling, and investigations.
• Ability to prioritise work and handle multiple deadlines.
• 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.
• Eligibility for QP status is highly desirable.
• Occasional global travel may be required.