Walker Cole International is supporting a growing specialty pharmaceutical company in Cambridgeshire with their search for a Quality Assurance Manager (Clinical). This role will provide quality oversight across clinical development activities, ensuring compliance with global regulatory standards while supporting the development and commercialisation of therapies for patients with rare conditions.
The successful candidate will be responsible for:
*Providing Quality oversight across clinical development activities, ensuring compliance with ICH-GCP and global regulatory requirements.
*Acting as the Quality lead for development programmes, supporting quality strategy across pre-clinical, clinical and regulatory activities.
*Managing CRO and external supplier quality oversight, including audits, quality agreements and ongoing compliance monitoring.
*Partnering with clinical operations and development teams to embed quality and support the transition of products from development to commercialisation.
*Contributing to the continuous improvement of quality systems, including delivering GCP training and guidance to internal stakeholders.
The successful candidate with have:
*A degree in Life Sciences or a related scientific discipline.
*Clinical Quality Assurance experience within the pharmaceutical or life sciences industry across all phases of clinical development.
*Experience working with CROs and external partners, including vendor oversight or audit activities.
*Strong communication, stakeholder management and problem-solving skills with the ability to operate in a cross-functional environment.
Quality Manager | QA Manager | Good Clinical Practice | GCP | Clinical | Phase I | Phase II | Phase III | Early Phase | Development | R&D | Quality Assurance | GxP | Audit | QMS | Quality Management System
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