Clinical Quality Assurance Manager

TN United Kingdom; Manchester; Hybrid; GBP 45,000 - 70,000; Full time

Job summary

An established industry player is seeking a Clinical Quality Assurance Manager to oversee quality and compliance activities in a hybrid role. This position is crucial for supporting the testing and registration of diagnostic tests across a diverse portfolio. You will lead a dedicated team, ensuring adherence to GCP practices while managing compliance during global trials. This role offers the opportunity to work cross-functionally with multinational teams and contribute to significant projects in the life sciences sector. If you are passionate about quality assurance and regulatory compliance, this role is perfect for you.

Qualifications

• 5+ years of experience in a GCP environment.
• Knowledge of IVD or medical device regulations is desirable.

Responsibilities

• Lead the Clinical QA team and ensure compliance during trial activities.
• Review clinical documentation and contribute to compliance KPI reporting.

Skills

GCP practices

Regulatory inspections

Excellent communication

Team collaboration

Education

Bachelor's degree in Life Sciences

Relevant certifications

Job description

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].