Clinical Quality Assurance Manager

Clinical Quality Assurance Manager

Posted 6 days ago by SRG on Reed

£46,000 Per year
Undetermined
Undetermined
Manchester, Lancashire

Summary: The Clinical Quality Assurance Manager role is a 12-month contract position based in Greater Manchester, focused on overseeing quality and compliance in global clinical trial activities for a leading diagnostics organization. The position requires a proactive professional to lead the Clinical QA team, ensuring adherence to regulatory standards and high-quality diagnostic studies. The role also involves collaboration with Clinical Affairs and participation in audits and inspections. This opportunity allows for significant contributions to impactful clinical programs within an innovative organization.

Key Responsibilities:

  • Provide leadership and support to the Clinical QA team, managing workload and offering expert guidance
  • Collaborate with the Clinical Affairs team to maintain trial compliance, addressing issues such as deviations and complaints
  • Review trial documentation and Clinical Affairs SOPs to ensure ongoing compliance
  • Contribute to the reporting of key Clinical Affairs compliance metrics
  • Participate in the internal audit programme and act as a Subject Matter Expert during inspections and audits

Key Skills:

  • Degree (or equivalent experience) in a relevant discipline
  • Proven background within quality in a Clinical environment
  • Qualified Auditor with demonstrable knowledge of GCP
  • Experience working with IVD or medical device regulations is highly desirable
  • Flexibility to travel internationally (up to 10%)

Salary (Rate): 46000

City: Manchester

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other