Clinical Quality Assurance Manager (12 months fixed-term contract)

Summary: The Clinical Quality Assurance Manager at QIAGEN is responsible for overseeing quality and compliance within the Clinical Affairs team during a 12-month fixed-term contract. This role involves managing workload distribution, ensuring compliance in clinical trials, and reviewing relevant documentation. The position requires a strong background in Good Clinical Practice (GCP) and experience in regulatory inspections. The successful candidate will contribute to a dynamic and diverse team focused on improving science and healthcare.

Key Responsibilities:

• Oversee division of workload and support the Clinical QA team.
• Ensure compliance during trial activities, including managing deviations and complaints.
• Review clinical relevant documentation throughout the clinical trial.
• Coordinate and provide input to reporting of Clinical Affairs compliance KPIs.
• Participate in the QIAGEN Internal Audit program.
• Review Clinical Affairs SOPs.

Key Skills:

• Degree-level qualification or equivalent experience.
• Minimum 5 years’ experience in a GCP environment with knowledge of GCP practices.
• Desirable: working knowledge of IVD or medical device regulations.
• Qualified Auditor.
• Experience as a Subject Matter Expert in regulatory inspections and audits.
• Willingness to travel internationally up to 10%.
• Excellent communication and interpersonal skills.

Salary (Rate): undetermined

City: Manchester

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: fixed-term

Seniority Level: Senior

Industry: Other