Clinical Quality Assurance, Senior Specialist
hace 4 días
About QIAGEN
At the heart of our business is a vision to make improvements in life possible. We are on an exciting mission to drive innovation and continuous improvement in science and healthcare.
We value our employees as our most valuable asset – over 6,000 strong across more than 35 locations worldwide. Our ambition is to foster outstanding and passionate teams, continually seeking new talent to join us.
If you're looking to advance your career, eager for new challenges and opportunities, enjoy working in dynamic international teams, and want to make a real impact on people's lives, then QIAGEN is where you belong.
Job Description
An exciting new role has arisen within our Manchester Quality Assurance team. The successful candidate will be responsible for quality and compliance oversight of the activities performed by the Clinical Affairs team at QIAGEN, supporting the testing and registration of diagnostic tests covering a diverse portfolio of indications. This scope includes global trials with multi-centre management from various locations.
Key Responsibilities:
• Collaborate with members of the Clinical Affairs team to ensure compliance during trial activities – e.g., closure of deviations, complaints, etc.
• Represent Clinical QA as a member of project teams for planned and ongoing clinical trials, including quality review of clinically relevant documentation.
• Support qualification and perform independent QA audits of clinical study sites.
• Participate in our internal audit program.
• Review Clinical Affairs SOPs.
Requirements:
• Degree qualification in a relevant subject or equivalent employment experience.
• Proven working experience as a Clinical Research Associate or similar, with knowledge of relevant regulations, standards, guidelines, and best practice.
• Desirable: Working knowledge of In Vitro Diagnostic or Medical Device Regulations.
• Desirable: Experience as an Auditor and/or Subject Matter Expert in regulatory inspections.
• Willingness and availability to travel internationally (Europe + USA) up to 10%.
What We Offer:
At QIAGEN, we act with passion, driving innovation and continuous improvement. We offer a competitive salary range of £70,000-£90,000 per annum, depending on experience.
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