Clinical Quality Assurance Manager

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 the Clinical Affairs team and participation in audits and inspections. This opportunity is ideal for someone looking to make a significant impact in a dynamic and innovative environment.

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