QA specialist - GCP
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our Quality Assurance department is currently looking for a QA specialist - GCP to strengthen the team. In the first year the focus will be on getting GCP inspection ready.
Description of the role:
As a QA Specialist-GCP (Good Clinical Practices) you will be responsible for the GCP related activities and processes at ProQR and external CRO’s/other vendors involved in the clinical trials, including but not limited to:
- involvement in clinical document review and approval
- further development, optimization and maintenance of the clinical quality system
- support the development of procedures and systems and ensure compliance of in-house and outsourced clinical activities with GCP
- Support in training needs and design and perform/organize internal GCP training
- perform internal and external GCP compliance audits
- participating with the clinical operations team to cover the QA aspects of the clinical trials
- support in various improvement projects
- active/coordinating role in GCP inspection readiness
- Representation of ProQR during GCP inspections
You will be working closely with the other QA specialist-GCP and with several departments like Clinical Operations, Clinical Science, PV and Regulatory Affairs. You will be reporting to the VP Quality Assurance.
Location: Leiden, NL.
We expect the QA specialist- GCP to have:
- HBO+ Education level
- Preferable at least 5 years of working experience in a QA GCP environment
- Experience in GCP inspection readiness projects
- Excellent knowledge of spoken and written English
Skills and competencies that are required for making the difference:
- Decisive and proactive
- Accurate and quality aware
- Autonomous and also a teamplayer
- A nice person :-)
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
- A competitive salary
- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premium-free pension plan
- A commuting allowance
- A subsidized staff restaurant
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position.
You can contact Laura Faber via email@example.com if you have any questions.
Please note that a screening is part of our selection procedure.