QA Officer

Work for an Organization that brings innovative therapies to patients worldwide.

VectorY combines the potential of antibodies and gene therapy to develop long-lasting therapeutic solutions for large disease areas of high unmet medical need. Founded in August 2020, and based in the Amsterdam Science Park, VectorY is a fully integrated gene therapy company focused on the development of innovative therapeutics for treatment of neurodegenerative diseases such as ALS and Huntington’s disease. With R&D facilities in Amsterdam, VectorY develops proprietary & partnered programs based on its novel AAV-based vectorized antibody gene therapy platform. 

Short description of the position

As a QA Officer, you will be part of a small Quality Assurance team which is responsible for building the VectorY quality management system needed to bring our first product to the clinic. Your primary responsibility is to maintain and optimize the Simploud Quality Management System (QMS) for document storage, control and training. You will also pro-actively contribute to quality improvements and will be involved in drafting SOPs and other quality related documents. The QA officer will be part of a multi-disciplinary project team and will be involved in review of GMP manufacturing and GLP toxicology study documents from outsourcing partners.

 

Main responsibilities of the role

  • Maintain and optimize the QMS.

  • Perform QA review of pharmaceutical documents, facilitate digital document approval and store documents in the QMS.

  • Set-up and maintain QA control tools, such as SOP lists, audit overviews, deviation & CAPA lists, inventory of approved GMP manufacturing documents, etc.

  • Support VectorY colleagues to address technical issues and troubleshooting associated with the use of site Quality Systems.

 

Skills and Qualifications:

  • A Bachelor degree in life science, biotechnology or related subject with QA experience, preferably in early-stage biotech or pharmaceutical industry.

  • Basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

  • Experience with QMS systems, ideally Simploud.

  • Proficient in the English language verbally and in writing.

  • Knowledge of QA requirements for pharmaceutical manufacturing.

Your Natural Strengths and Drivers

  • Ability to work independently with proven problem-solving skills.

  • Interest and experience implementing new systems and procedures.

  • Ability to work in a fast paced, rapidly changing environment, proactive attitude, optimization, can do mentality.

     

Working at VectorY

Challenging and varied work with a real impact. We offer an attractive salary package, 30 holiday days and every opportunity to develop yourself. An authentic experience within a young, ambitious biotech company on the path to bring innovative therapies to patients worldwide.

Interested? Please apply and send your resume to talent.acquisition@vectorytx.com to the attention of Sandra Lemmens.