Clinical Quality Assurance, Senior Specialist

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Overview

At the heart of QIAGEN's business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

Position Description

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

Position Requirements

- Degree qualification in a relevant subject, or equivalent employment experience

- Proven working experience and knowledge of clinical regulations, standards, guidelines and best practice e.g. CFR 812, BIMO, ISO standards, ICH GCP

- Demonstrable working knowledge of global In Vitro Diagnostic Regulations (EU IVDR, US 21CFR820)

- Qualified Auditor and experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits e.g. NB audit

- 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

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

- Opportunity to join internal QIAGEN communities

- Enhanced maternity package

- Flexible working options
- Bonus/commission
- 25 days annual leave (potential to increase linked to service)

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 race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.