Quality Assurance Manager

Quality Assurance Manager

Posted 1 day ago by SRG

£50,000 Per year
Undetermined
Undetermined
United Kingdom

Summary: The Clinical Quality Assurance Manager will oversee global clinical activities for a leading diagnostics organization, ensuring quality and compliance in clinical trial operations. This 12-month contract role requires a proactive professional with expertise in clinical quality assurance. The position involves leadership, collaboration with clinical teams, and participation in audits and inspections to uphold regulatory standards.

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 program 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): £50,000.00 yearly

City: undetermined

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

SRG are proud to be working on behalf of a leading global diagnostics organization, currently seeking an experienced Clinical Quality Assurance Manager to oversee their Global Clinical activities. Our client is a pioneering force in science and healthcare. Improving lives across the world, through their continuous innovation, developing and delivering life-changing diagnostic solutions.

The Role: This is a 12-month contract position ideal for a proactive and knowledgeable Clinical QA professional. You will take a senior role in overseeing quality and compliance across global clinical trial activities, supporting the delivery of high-quality, regulatory-compliant diagnostic studies.

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 program and act as a Subject Matter Expert during inspections and audits

Requirements:

  • 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%)