Biologist, Chemist as Quality Manager - Clinical Quality Assurance, Compliance (m/f/d)

An exciting new role has arisen within the QIAGEN Manchester Quality Assurance team. The successful candidate will take on responsibility for quality and compliance oversight of the activities performed by the Clinical Affairs team at QIAGEN, in support of the testing and registration of diagnostic tests covering a diverse portfolio of indications. The scope of the trials is global and includes multi-centre trials managed out of several different locations.

Key responsibilities:

• Work 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 clinical relevant documentation
• Support qualification and perform independent QA audits of clinical study sites
• Participate in the QIAGEN internal audit program
• Review Clinical Affairs SOPs

• 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%
• Ability to work independently while exercising good judgement and decision making within defined practices and policies
• Excellent communication and interpersonal skills with the ability to work effectively with multinational/ cultural teams and individuals

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to color, gender, age, national origin, religion, romantic orientation, gender identity, status as a veteran, or disability.