Clinical Quality Assurance Manager (FTC)

JR United Kingdom; Manchester; Hybrid; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Clinical Quality Assurance Manager for a 12-month fixed-term contract. This hybrid role, requiring 3 days on-site in Manchester, involves overseeing quality and compliance activities within the Clinical Affairs team. The successful candidate will ensure adherence to Good Clinical Practice (GCP) while managing a diverse portfolio of diagnostic tests and instruments. With responsibilities including workload distribution, compliance monitoring, and participation in audits, this position is ideal for a strong team player with excellent communication skills and a proven track record in regulatory environments. If you're ready to make an impact in a dynamic setting, this opportunity is for you.

Qualifications

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

Responsibilities

• Oversee workload distribution and support the Clinical QA team.
• Ensure compliance during trial activities and review clinical documentation.
• Participate in the Internal Audit program and update Clinical Affairs SOPs.

Skills

GCP practices

Regulatory inspections

Communication skills

Interpersonal skills

Education

Qualified Auditor certification

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 performed by the Clinical Affairs team. The team supports testing and registration of diagnostic tests/instruments across a diverse portfolio of indications. The scope of trials is global, including multi-center trials managed from various locations.

Key responsibilities:

• Oversee workload distribution, advise, and support the Clinical QA team as a senior member.
• Ensure compliance during trial activities such as deviation closure and handling complaints.
• Review clinical documentation throughout the trial process.
• Coordinate and contribute to reporting of Clinical Affairs compliance KPIs.
• Participate in the Internal Audit program.
• Review and update Clinical Affairs SOPs.

Position Requirements:

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

Please note: This hybrid role requires 3 days per week on-site in Manchester. Candidates must have the full right to work in the UK; sponsorship is not offered.