Quality Associate

Quality Associate

Cycle Company: Cycle Pharmaceuticals Ltd

Position Summary: This full-time position is working in our Cambridge office on a hybrid basis (minimum 3 days in the office).

The opportunity

Cycle Pharmaceuticals is growing rapidly, and as we expand our product portfolio, we’re strengthening our Quality team. We’re now looking for a Quality Associate to strengthen our Quality Assurance function and support the patients who rely on our drugs to provide them with a better quality of life.

In this role, you’ll work within our Quality Management System to maintain compliance with GxP standards and collaborate closely with our contract manufacturing partners. You’ll contribute to improving our GxP and business systems, work across multiple therapeutic areas, and help enhance our quality processes to support both company growth and patient safety.

Our Company

At Cycle Pharma, 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.

If you want to know more about what we do then, why not check out our website below and take a look at some of our patient stories:  Patient Stories - Cycle Pharma

What you’ll be doing in this role:

• Review, approve and maintain GMP, GDP and GVP documentation within the eQMS, supporting the commercial supply of API and finished products.
• Provide quality oversight of API, finished product CMOs and contract packaging partners to ensure consistent compliance and performance.
• Support management of stability across the commercial product portfolio.
• Act as a key point of contact for quality-related queries from internal teams and partners related to commercial products.
• Contribute to regulatory inspections as well as customer and internal audits.
• Maintain a constant state of audit readiness across all responsible activities.
• Manage and continuously improve owned SOPs.
• Partner with Regulatory Affairs (PV, Labelling, and CMC) to provide QA input and support.
• Complete all required training in a timely manner and stay current with compliance expectations.
• Help shape and strengthen company Quality Systems, driving a strong and proactive quality culture.
• Represent the department on cross-functional project teams, delivering on assigned tasks as required.
• Maintain knowledge of relevant guidance GMP, GDP and GVP and provide advice on queries received.

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.
• Confident at building and maintaining strong working relationships across the organisation and with external partners.
• Strong analytical, organisational and problem-solving skills.
• Quality focused and high attention to detail.

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
• Corporate Gym membership
• 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.