Clinical Quality Assurance Manager - FTC
Posted 1 day ago by Cpl Life Sciences
£50,000 Per year
Fixed-Term
Remote
United Kingdom
Summary: The Clinical Quality Assurance Manager will oversee quality and compliance for the Clinical Affairs team during a 12-month fixed-term maternity cover contract. This remote position requires occasional travel to the North West of England and involves managing compliance for global clinical trials related to diagnostic tests and instruments. The role demands significant experience in a GCP environment and a strong ability to work collaboratively across teams.
Key Responsibilities:
- Oversee division of workload and support the Clinical QA team.
- Ensure compliance during trial activities, including closure of deviations and complaints.
- 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.
Key Skills:
- Degree-level qualification or equivalent experience.
- Minimum 5 years’ experience in a GCP environment.
- Working knowledge of GCP practices.
- Desirable: working knowledge of IVD or medical device regulations.
- Qualified Auditor.
- Experience as a Subject Matter Expert in regulatory inspections and audits.
- Willingness to travel internationally up to 10%.
- Excellent communication and interpersonal skills.
- Ability to work cross-functionally with multinational teams.
Salary (Rate): £50,000 yearly
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: fixed-term
Seniority Level: Senior
Industry: Other
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