Senior QA Officer

About HUB:

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 provides preclinical drug development services and research collaboration for and with pharma industry. HUB’s research is aimed at the expansion of the Organoid Technology platform by developing new disease models, generation of comprehensive living biobanks of well-characterized organoids and developing assays for drug development and validation. Finally, the Organoid Technology enables predictive diagnostics and clinical patient stratification.

We are currently seeking a highly motivated Senior QA Officer (32 – 40 hrs)

Scope of position:

A Senior 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. You report to the QA Manager.

You integrate requirements with regards to  Supplier Evaluation, Equipment Maintenance, Facility management, Manufacturing, Vigilance and Quality Control of products and processes in the consolidation of the QMS.

As Senior 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.

You are challenged by optimizing QA processes and tools.

Responsibilities:

  • Driving HUB’s development of the QMS,
  • Ensuring HUB’s compliance to requirements defined in the QMS,
  • Writing QA Documentation such as SOPs and LMs, related to technical and managerial activities and reviewing the aforementioned documents drafted by other departments and/or QA Officer,
  • Assisting the Research Team in the compilation of Technical Documentation for In Vitro Diagnostic medical devices and acting as moderator 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,
  • Organizing and reporting Management Reviews of the QMS,
  • Ensuring employee awareness of individual and collective contribution to QA compliance.

Qualifications:

Suitable candidates have a Bachelor or Master preferably in the field of Life Sciences or another relevant technical area followed by a minimum of 10 years of relevant work experience in a commercial, ISO certified (or alike) environment.

Ideally, you have gained extensive experience in building a flexible and sustainable QMS, including compliance to laws and regulations related to the design and development, manufacturing and quality control of In Vitro Diagnostic medical devices (IVD). You are acquainted with diagnostic testing procedures, including applicable global quality standards.

In particular you bring the following knowledge and skills:

  • Experience in implementing requirements of ISO 13485 and preferably also of ISO 15189;
  • 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 with writing and reviewing standard operating procedures;
  • Advanced Excel skills;
  • Advanced Word skills;
  • English and Dutch language proficiency.

Excellent communications and collaboration skills round off your profile.

What we offer:

Genuinely meaningful work as part of a company with unwavering commitment to apply its Organoid Technology globally for the benefit of the patients.

Generous annual leave of 30,5 days plus national holidays (fulltime equivalent).

Pension Plan with 2/3 contribution paid by HUB.

A unique opportunity to be part of further development and implementation of this innovative technology.

Interested?

Please send your cover letter and resume, in English to; HR@huborganoids.nl

We look forward to hearing from you!

 

 

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