Job Description

A new exciting role has arisen within the QIAGEN Manchester Quality Assurance team. The successful candidate will take on responsibility for assuring the quality and compliance of external verification and validation studies. This includes audits of clinical studies as well as quality oversight of internal related verification/validation activities.

You will require both the experience and the vision to create a robust system in conjunction with our existing Clinical Affairs and Quality Affairs departments. Whilst the initial phase of the role will require operational execution of activities personally, there is ample opportunity for the right person to develop the role/function in the coming years. You will be playing a vital role in a company with patient and customers at the heart of everything we do, and dedicated to making improvements in life possible.

What we offer

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.

We offer:

• Possibility to develop in an international company
• Attractive pension
• Private Healthcare
• Private Dentalcare
• Gym membership contribution
• Access to an Employee Assistance Programme
• A range of retail discounts and offers
• Bonus/commission
• 25 days annual leave (potential to increase linked to service)

Required Knowledge, Skills, and Abilities

BA/BSc qualification (or equivalent) required. Demonstrable, working knowledge of global In vitro Diagnostic Regulations (minimum EU and USA). In addition significant experience of clinical regulations, standards, guidelines and best practice e.g. CFR 812, BIMO, ISO standards, ICH guidelines. Qualified Auditor. Experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits e.g. NB audit. Ability to work cross-functionally. Excellent knowledge of the in vitro diagnostic industry including product development processes (ISO13485). Ability to work independently while exercising good judgment and decision making within defined practices and policies. Proficient in reading, analyzing and interpreting scientific and technical information. Ability to demonstrate and convey high performance, high standards culture. Skills in MS Office packages (e.g. Excel, Word, Outlook, PowerPoint, Project). Willingness to travel internationally up to 50%. Strong communication and interpersonal skills Ability to work with multinational/cultural teams and individuals Strong attention to detail and excellent organizational skills required Proficient in defining problems, establishing facts and drawing conclusions and mitigation plans. Fluent in English language both oral and written.