Job Title: Clinical Quality Assurance Manager - IVDs/Medical Devices
Job Type: 12 months fixed-term contract, Maternity cover
Location: Remote UK-based with occasional travel to the North West, England
Remuneration: £50,000 + 10% Bonus
Cpl Life Sciences is partnering with a leading organisation that uses 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. The scope of the trials is global and includes multi-centre trials managed out of several different locations.
Key responsibilities:
* 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
* Coordinate and provide input to reporting of Clinical Affairs compliance KPIs
* Participate in the Internal Audit program
* Review Clinical Affairs SOPs
Position Requirements:
* Degree-level qualification (or equivalent experience)
* Minimum 5 years’ experience in a GCP environment with demonstrable, working knowledge of GCP practices
* Desirable: working knowledge of IVD or medical device regulations
* Qualified Auditor
* Experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits
* Willingness to travel internationally up to 10%
* A strong team player with excellent communication and interpersonal skills who puts value into working cross functionally with multinational/ cultural teams and individuals
Please note this role does not offer sponsorship and will need candidates to hold the full right to work in the UK and be BASED in the UK.
For more information please contact me at lucy.kirkaldy@cpl.com