Quality Director UK
14 days ago
Manchester
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.