Quality Manager

Quality Manager (Cambridge, UK) Cycle Company: Cycle Pharmaceuticals Ltd Position Summary: This full-time position is within the Quality department in our Cambridge office on a hybrid basis (minimum 3 days in the office). The opportunity Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its Quality Assurance Department as a Quality Manager As our Quality Manager, you'll play an important role in ensuring quality and compliance across the product lifecycle, from development through to commercial supply. You'll provide quality oversight of our external manufacturing partners (CMOs), supporting activities including manufacturing, distribution, and testing, while helping to ensure the timely release of Investigational Medicinal Products (IMPs) and finished medicines for patients around the world. Working closely with the Director of Quality Assurance, you'll help drive the continuous improvement of our Quality Management System (QMS), ensuring compliance with regulatory requirements and embedding a strong culture of quality throughout the organisation. You'll collaborate with colleagues across multiple functions, contribute to strategic projects, and build a broad internal network, giving you the opportunity to make a meaningful impact on both our growth ambitions and the patients we serve. We're open to applications at both Manager and Senior Manager level. Whether you're looking to take the next step in your career or bring your existing expertise to a growing, patient-focused organisation, this is a fantastic opportunity to broaden your experience, develop your technical knowledge in meaningful ways and make a real impact on our growth and on the patients we support. Our Company At Cycle, we believe that Every Single Patient Matters . This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen. Our core focus areas include oncology, rare metabolic, immunological, and neurological genetic conditions, where we improve existing drugs, repurpose them for new uses, and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice. Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website below and look at some of our patient stories: Patient Stories - Cycle Pharma What you’ll be doing in this role: • Implement and maintain the QMS to ensure compliance with regulatory requirements (FDA, MHRA, ICH, etc.) and internal standards. • Monitor compliance with applicable regulations and standards, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP). • Prepare for and assist in regulatory inspection audits. • Assess, identify, and mitigate risks associated with product development and clinical trials, ensuring adherence to best practices. • Ensure that all quality-related documents and records for the area you are responsible for are accurately maintained, reviewed, and approved, including Standard Operating Procedures (SOPs) and deviation reports. • Lead initiatives for quality improvement and process optimization, leveraging data analysis and stakeholder feedback. • Prepare and circulate quality metrics and reports to senior management, identifying trends and areas for improvement. • Support review an