Job Title: Clinical Quality Assurance Manager Job Type: 12 months fixed-term contract, Maternity cover
Manchester, UK (hybrid) 3x a week on site
Remuneration: £40,000 - £46,000 + 10% Bonus
Cpl Life Sciences is partnering with a leading organisation that use technologies to help customers extract, analyze, and interpret molecular data from samples containing DNA, RNA, and proteins.
Due to maternity leave, we are looking for an experienced candidate to take responsibility for quality and compliance oversight of the activities performed by the Clinical Affairs team. The function supports the testing and registration of diagnostic tests/ instruments covering a diverse portfolio of indications. As a senior member of the Clinical QA team, take responsibility for overseeing division of workload, advising, and supporting the team as required
Work with members of the Clinical Affairs team to ensure compliance during trial activities e.g. closure of deviations, complaints etc.
Review Clinical relevant documentation throughout the clinical trial
Desirable: working knowledge of IVD or medical device regulations
Experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits
Willingness to travel internationally up to 10%
This role will be a hybrid-based position with 3x a week required on site in Manchester.