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.