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Cycle Pharmaceuticals

Repurposes drugs for rare diseases

Quality Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeCambridge, UK

About the Job

Requirements

  • A BSc or MSc in Life Sciences or a related discipline, or relevant technical experience.
  • Significant experience in pharmaceutical Quality Assurance, preferably within the pharmaceutical industry.
  • Strong working knowledge of Good Distribution Practice, Good Manufacturing Practice, and Good Pharmacovigilance Practice.
  • Strong written and verbal communication skills.
  • Ability to work proactively and autonomously as well as collaboratively.
  • Ability to build and maintain strong working relationships across the organisation and with external partners.
  • Strong negotiation skills and confidence challenging co-workers or third parties while maintaining relationships.
  • Initiative and ability to solve problems and work unsupervised.
  • Strong analytical, organisational, and problem-solving skills.
  • Quality focus and high attention to detail.
  • Ability to take ownership and accountability for delivering objectives on time and to budget.
  • Ability to prioritise and organise assigned work effectively.

Responsibilities

  • Implement and maintain the Quality Management System to ensure compliance with regulatory requirements and internal standards.
  • Monitor compliance with applicable regulations and standards, including Good Clinical Practice, Good Manufacturing Practice, and Good Distribution Practice.
  • Prepare for and assist with regulatory inspection audits.
  • Assess, identify, and mitigate risks associated with product development and clinical trials, ensuring adherence to best practices.
  • Maintain, review, and approve quality-related documents and records, including Standard Operating Procedures and deviation reports.
  • Lead quality improvement and process optimisation initiatives using data analysis and stakeholder feedback.
  • Prepare and circulate quality metrics and reports to senior management, identifying trends and areas for improvement.
  • Support the review and approval of product specifications, batch documentation, Certificates of Analysis, stability data, process validation protocols and reports, and packaging documentation to ensure conformance with procedures, Good Manufacturing Practice, and regulatory requirements, including support for Qualified Person certification.
  • Communicate and collaborate with functional areas, represent the department on cross-functional teams, and build effective working relationships.
  • Support project teams as the Quality Subject Matter Expert to address quality concerns and support product development goals.
  • Contribute to annual budget discussions and identify spending and savings for the year ahead.
  • Represent the department on cross-functional project teams, contribute to budget and timeline discussions, and ensure the wider department is aware of assigned actions.
  • Perform line management responsibilities for direct reports.
  • Model management behaviours and create an environment in which people are encouraged and able to demonstrate them.
  • Provide training and development for direct reports and relevant stakeholders to support their continued professional development.

Desired Qualifications

  • Experience in pharmaceutical Quality Assurance, preferably within the pharmaceutical industry.

About the Company

Cycle Pharmaceuticals

Repurposes drugs for rare diseases

Cycle Pharmaceuticals develops and sells medicines that improve existing drugs for rare genetic diseases. It focuses on repurposing, reformulating, and reintroducing generic medications to treat rare metabolic, immunological, and neurological conditions (such as HT-1, PKU, MS). Its products are delivered as ready-to-use therapies in the United States, aided by the Cycle Vita patient support program that helps with education, insurance coordination, and affordability to ensure patients can stay on treatment. Unlike some peers that chase new molecular entities, Cycle builds value by optimizing existing drugs to fit patient needs, aiming for reliable cash flow, profitability, and the ability to fund acquisitions and growth. The company also operates a social mission to provide free medicines in developing countries. Overall, its goal is to improve quality of life for people with rare diseases while expanding access and maintaining sustainable operations.

Company size
201-500
Company stage
Debt Financing
Total funding
$25M
Headquarters
Cambridge, United Kingdom
Founded
2012

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