Quality Director UK
Location: UK-based (Remote with 2 days per week on-site)
Employment Type: Full-time, Permanent
Requirements: Qualified Person (QP) status & sterile manufacturing experience
About the Opportunity
We are seeking an exceptional Quality Director to lead the Quality function for our client’s UK aseptic pharmaceutical operations. This is a senior strategic role ideal for a proven leader with deep experience in sterile/aseptic manufacturing and the authority to act as a Qualified Person (QP) under UK/EU regulations.
The Quality Director will set the vision for Quality across the organisation, ensure regulatory robustness, and drive a culture of excellence. While the role can be performed remotely, regular on-site leadership is essential—a minimum of two days per week at the manufacturing facility.
Key Responsibilities:
* Provide strategic leadership and executive oversight for all Quality Operations and Quality Systems
* Act as the site’s Qualified Person (QP) for batch certification in accordance with MHRA and EU GMP guidelines
* Lead, coach, and develop Quality teams, ensuring high performance and strong succession planning
* Ensure GMP compliance across aseptic operations, including environmental monitoring, sterility assurance, validations, and media fills
* Serve as the primary Quality authority during regulatory inspections and external audits
* Oversee deviation management, CAPA closure, change controls, and risk assessments
* Partner closely with Production, Technical, and Regulatory Affairs to support continuous improvement and inspection readiness
* Provide Quality leadership during new product introductions, process changes, and technology upgrades
* Report regularly to senior leadership on Quality performance, strategic risks, and regulatory trends
About You:
* Eligible to act as a Qualified Person (QP) in the UK (Directive 2001/83/EC)
* Significant experience in aseptic/sterile pharmaceutical manufacturing is essential
* Proven track record leading Quality teams at a senior level (Head of Quality, Director, or similar)
* Deep knowledge of MHRA and FDA expectations, EU GMP Annex 1, and sterile product quality requirements
* Strong leadership presence with the ability to influence at all levels
* Excellent judgement, communication skills, and a proactive approach to risk and compliance
* Comfortable working remotely but committed to on-site leadership for 2 days each week
What’s on Offer
* Highly competitive executive salary
* Annual bonus scheme
* Private healthcare
* Generous holiday and wellbeing benefits
* Leadership influence across a growing and strategically important aseptic facility
* Opportunity to shape Quality strategy and drive innovation in sterile manufacturing
How to Apply
If you are a QP and experienced Quality leader with a passion for aseptic pharmaceuticals, we’d love to hear from you!
Key Words:
Quality Assurance, QA, compliance, UK, MHRA, Director, Senior, Management, manager, leader, head, GMP, QP, Qualified Person, pharma, pharmaceutical, sterile, injection, injectable, aseptic, terminal sterilization.