Clinical Quality Assurance Manager

Job Description: Clinical Quality Assurance Manager, Manchester

Client: Cpl

Location: Manchester, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: fc20fec1550d

Job Views: 6

Posted: 05.05.2025

Expiry Date: 19.06.2025

Job Description

Job Title: Clinical Quality Assurance Manager

Job Type: 12 months fixed-term contract, Maternity cover

Location: Manchester, UK (hybrid) 3x a week on site

Cpl Life Sciences is partnering with a leading organization 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 seeking an experienced candidate to oversee quality and compliance activities of the Clinical Affairs team. This team supports testing and registration of diagnostic tests/instruments across a diverse portfolio of indications. The trials are global, multi-center, and managed from various locations.

Key Responsibilities

• Lead and support the Clinical QA team, overseeing workload and providing guidance
• Ensure compliance during trial activities, including deviations and complaints
• Review clinical documentation throughout trials
• Contribute to reporting of Clinical Affairs compliance KPIs
• Participate in internal audit programs
• Review and update Clinical Affairs SOPs

Position Requirements

• Minimum 5 years’ experience in a GCP environment with knowledge of GCP practices
• Desirable: knowledge of IVD or medical device regulations
• Experience as a Subject Matter Expert in regulatory inspections and audits
• Willingness to travel internationally up to 10%
• Strong team player with excellent communication skills, capable of working cross-functionally with multinational and multicultural teams

This role is hybrid, requiring 3 days on-site in Manchester. Candidates must have full right to work in the UK; sponsorship is not available.

For more information, please contact us at (contact details).

#J-18808-Ljbffr