Hubrecht Organoid Technology (HUB) is a fast-growing biotech company, founded on the pioneering work of Prof. Dr. Hans Clevers who discovered methods to grow stem cell-derived human epithelial “mini-organs” (organoids) from tissues of patients with various diseases including cancer and cystic fibrosis. HUB builds comprehensive living biobanks of well-characterized organoids and develops assays for drug screening and validation. The HUB Organoid Technology enables predictive diagnostics and clinical trial patient stratification.
We are currently seeking a highly motivated QA Officer (32 – 40 hrs)
Scope of position:
A QA Officer at HUB supports service contracts and research projects, commissioned by predominantly pharmaceutical companies. This position allows you to drive the development of a state-of-the-art Quality Management System (QMS) with the aim to achieve ISO certification and/or accreditation in the near future to support the HUB preclinical services and future in vitro diagnostic medical device (IVD) development of organoids. You report to the QA Manager.
As QA Officer at HUB, you work in close liaison with technicians, researchers and Regulatory Affairs’ colleagues. You interact with external parties such as the Notified Body and other external auditors and you represent the company at relevant meetings.
The successful candidate ensures the implementation of QMS in the context of the project Quality in Control to support the growth of HUB Organoid Technology, providing patients access to novel treatments.
- Driving HUB’s development of the QMS,
- Ensuring HUB’s compliance to requirements defined in the QMS,
- Writing QA Documentation such as SOPs,
- Assisting the Research Team in the compilation of technical documentation for IVDs to be applied in a medical laboratory,
- Acting as facilitator for associated Risk Assessments according to ISO 14971,
- Organizing and conducting internal audits as Lead Auditor,
- Creating in-depth training context regarding applicable laws and regulations for HUB’s internal use and training its employees,
- Ensuring employee awareness of individual and collective contribution to QA compliance.
Suitable candidates have a Master, preferably in the field of Life Sciences or a comparable area, followed by a minimum of 3-5 years of relevant work experience in a commercial, ISO-certified (or alike) environment.
In addition, HUB strongly encourages candidates with an equivalent or advanced educational background (such as Bachelor or PhD) to apply for this position.
Ideally, you have gained experience in maintaining a flexible and sustainable QMS, including compliance to laws and regulations related to the design and development, manufacturing and quality control of IVDs.
In particular you bring the following knowledge and skills:
- Experience with the establishment of a technical dossier for an IVD according to the EU IVD directive 98/79/EC and/or EU IVD Regulation 2017/746;
- Experience in implementing requirements of ISO 13485;
- Experience with writing and reviewing standard operating procedures;
- Strong written and oral skills in English and preferably Dutch.
Excellent communications and collaboration skills round off your profile.
You are challenged by optimizing QA processes and tools.
What we offer:
A high paced, professional and international environment,
Genuinely meaningful work as part of a company with unwavering commitment to apply organoid technology globally for the benefit of the patients,
Generous annual leave of 30,5 days (FT) plus national holidays,
Pension Plan with 2/3 contribution paid by HUB,
Healthy work-life balance with flexible working hours,
International work environment in a multi-cultural team,
Opportunity to grow in this position alongside HUB’s development.
Please send your cover letter and resume, in English to HR@huborganoids.nl
We look forward to hearing from you!