QA Specialist

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 specialist, you will be part of a small Quality Assurance team (Head of QA and QP) which is responsible for building the VectorY quality management system (QMS) needed to bring our first product to the clinic. Your primary responsibility is to support the development of the QMS and further implementation of the electronic Document Management System (eDMS). You will also pro-actively contribute to quality initiatives, review of quality documents and writing QA related SOPs. The QA specialistr will be part of multi-disciplinary teams and will be involved in review of GMP manufacturing documentation from outsourcing partners and of internal study documentation.

 

Main responsibilities of the role

  • Support development of the QMS

  • Manage quality related processes, such as but not limited to documentation control,

    deviations, CAPAs, change controls

  • Support further implementation and subsequent management of the eDMS

  • Create awareness in the organization with regards to quality

  • Perform QA review of quality documents e.g internal- and external study reports, GMP

    manufacturing documentation, SOPs etc.

  • Write QA related SOPs and documentation

  • Perform internal and external (vendor) audits

  • Give quality related training

  • Provide QA support to meet regulatory requirements

  • Proactively advise, support and act as sparring partner for the operational departments

  • Support with issues and troubleshooting associated with the product development activities

 

Skills and Qualifications:

  • A Bachelor/Master degree in life science, biotechnology or related subject

  • Thorough QA experience, preferably in early-stage biotech or pharmaceutical industry

  • Extensive knowledge of current Good Manufacturing Practices (cGMP) is essential. Basic

    knowledge of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) is

    preferred.

  • Experience with eDMS en eQMS systems

  • Proficient in the English language verbally and in writing

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 and a

    ‘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 before April 25th and send your resume to talent.acquisition@vectorytx.com to the attention of Sandra Lemmens.