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 (QA) department is currently looking for a QA Specialist GCP (Full-time) to join our team.
- Participate in the development, implementation, and maintenance of the company’s GCP quality management system and facilitate continuous improvement.
- Provide GCP QA oversight and support to internal staff and represent QA on GCP related project teams.
- Develop and implement annual audit strategies, and quarterly GCP audit schedules.
- Schedule, oversee and perform (either directly or via external auditors) routine and non-routine quality assurance audits to include, but not limited to: clinical investigator sites, vendors, process, and system.
- Assist in the selection of external auditors, coordinate audits, and associated documentation in a timely manner.
- Assure/coordinate proper and complete resolution of findings/non-compliant situations in a timely manner, including approval of corrective action/preventive action (CAPA) plans, as necessary.
- Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
- Participate in the preparation and conduct of inspections and audits performed by regulatory authorities and other parties.
Location: Leiden, NL
We expect our QA Specialist GCP to have:
- Bachelor’s Degree in a scientific discipline
- A strong working knowledge of GCP and ICH requirements
- Proven experience in the Pharmaceutical industry within QA GCP environment
- Excellent knowledge of spoken and written English
Skills and competencies that are required for making the difference:
- Strong verbal and written communication skills
- Excellent organization and multi-tasking skills
- Ability to think strategically in order to improve current processes
- Ability to work independently and prioritise with minimal supervision
- Ability to work effectively across a matrix organisation
- Proactive attitude
- Team player
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 Yessica de Brouwer via firstname.lastname@example.org if you have any questions.
Please note that a screening is part of our selection procedure.