Quality Manager

Cycle Pharmaceuticals; Cambridge; Hybrid; GBP 70,000 - 95,000; Full time

Benefits offered by this job

Private Health Insurance

Company pension

Performance bonus

Team building events

Agile working

Job summary

Cycle Pharmaceuticals is seeking a Quality Manager to lead QA activities in our Cambridge office on a hybrid basis (minimum 3 days in the office). You will provide quality oversight of CMOs, supporting manufacturing, distribution, and testing to ensure timely release of IMPs and medicines for patients worldwide.

Working with the Director of Quality Assurance, you will drive continuous improvement of the QMS, embed a culture of quality, and collaborate across functions on strategic projects.

Qualifications

• Significant experience in pharmaceutical Quality Assurance
• Strong knowledge of GDP, GMP and GVP
• Excellent written and verbal communication skills
• Ability to work proactively in a team and autonomously
• Ability to build relationships across the organisation and with external partners

Responsibilities

• Implement and maintain the QMS to ensure regulatory compliance
• Monitor compliance with GCP, GMP, GDP
• Prepare for regulatory inspection audits
• Lead quality improvement initiatives and process optimization
• Oversee document control and deviation handling
• Collaborate with cross-functional teams and external partners
• Support budgeting and resource planning for the quality department
• Provide training and development for team members

Skills

Quality Assurance

Regulatory knowledge

GxP

Stakeholder management

Analytical mindset

Communication

Team leadership

Problem solving

Education

BSc / MSc Life Sciences

Job description

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 and approve documents, including product specification, batch documentation, CofAs, stability data, process validation protocol and reports and packaging documentation, to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and represents department on cross functional teams.
• Support project teams as the Quality SME to address quality concerns and support product development goals.
• Contribute to the discussion and creation of the annual budget, identifying spend and savings for the year ahead.
• Lead the representation of the department on cross function project teams – input into discussions on budget and timelines, and ensure wider department are aware of assigned actions.
• Perform line management responsibilities for direct reports within the team.
• Acts as a role model for management attributes, demonstrating focus, flexibility and creativity, and create an environment in which people are encouraged and able to model these behaviours.
• Provide suitable training and development of all direct reports/relevant stakeholders to ensure their continued professional development.

The following skills and experience will be important in helping to set you up to succeed in this role:

• BSc / MSc in Life Sciences or a related discipline or relevant technical experience.
• Significant experience in pharmaceutical Quality Assurance, preferably within pharmaceutical industry.
• Strong working knowledge of GDP (Good Distribution Practice), GMP (Good Manufacturing Practice) and GVP (Good Pharmacovigilance Practice).
• Excellent written and verbal communication skills.
• Ability to work in a proactive and autonomous manner, as well as being part of a team.
• Ability to create and maintain strong working relationships across the organisation and with external partners.
• Strong negotiation skills, and confidence in challenging co-workers or third parties, whilst ensuring relationships are maintained.
• Enthusiasm and personal initiative to solve problems, a self-starter with ability to work unsupervised.
• Strong analytical, organisational and problem-solving skills, and the ability to think-outside the box.
• Quality focused and high attention to detail.
• Result-oriented and takes ownership and accountability to deliver objectives on time and to budget.
• High level of prioritisation and organisation to manage assigned work effectively.

What can we offer to you:

In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:

• Competitive salary based on experience
• A collaborative high performing work environment
• Performance based bonus
• Opportunity to join a fast growing and ambitious business
• Company pension scheme
• 100% employer paid membership for Private Health Insurance
• Life and Critical Illness Insurance
• Regular team building events and an agile working environment

Diversity and Inclusion statement:

At Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.

We value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.