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. Our most valuable assets are our employees – around 6000 in over 35 locations worldwide. Our ambition is to have outstanding and passionate people working in the best teams, and we are constantly seeking new talent to join us.
If you are looking to advance your career, seek new challenges and opportunities, enjoy working in dynamic, international, and 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 Quality Assurance team. Based at either our Barcelona or Manchester sites, the successful candidate will oversee quality and compliance activities performed by the Clinical Affairs team, supporting the testing and registration of diagnostic tests across a diverse portfolio of indications. The scope of the trials is global, including multi-center trials managed from various locations.
Key responsibilities include:
1. Work with the Clinical Affairs team to ensure compliance during trial activities, such as closure of deviations and handling complaints.
2. Represent Clinical QA as a member of project teams for clinical trials, including reviewing relevant documentation.
3. Support qualification and perform independent QA audits of clinical study sites.
4. Participate in the internal audit program.
5. Review Clinical Affairs SOPs.
Position Requirements
* Degree qualification in a relevant subject or equivalent employment experience.
* Proven experience in a GCP environment with knowledge of relevant regulations, standards, and guidelines.
Desirable:
* Knowledge of In Vitro Diagnostic or Medical Device Regulations.
* Experience as an Auditor and/or Subject Matter Expert in regulatory inspections.
* Willingness to travel internationally (Europe + USA) up to 10%.
* Ability to work independently with good judgment and decision-making skills.
* Excellent communication and interpersonal skills, with the ability to work effectively with multinational and cultural teams.
What we offer
At QIAGEN, our people drive our success. We foster a passionate, innovative, and collaborative workplace that encourages high performance and growth. We are committed to diversity and equal opportunity employment, welcoming applicants regardless of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, or disability.
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