Vacature

Senior QA Specialist

Locatie

Amsterdam

Job Description

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 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.

With R&D and manufacturing facilities in Amsterdam, VectorY develops proprietary & partnered programs based on its novel AAV-based vectorized antibody gene therapy platform. Product candidates are based on next generation vector technologies, which will enable a proprietary and highly scalable manufacturing process within VectorY’s own manufacturing facilities.

Job Description

The Senior Quality Assurance (QA) Specialist will be responsible to provide quality support for our AAV gene therapy programs at VectorY and performs all relevant activities related to product development and manufacturing to support our non-GMP and clinical production activities. The candidate will be responsible for managing and implementing the Laboratory Information Management System (LIMS) and Quality Management Systems (QMS).

You will interact with a cross functional team supporting R&D, Vector Development and Process Development teams.

  • Main responsibilities of the role

     

    • At least five years’ experience in a similar QA role
      • Lead the QA activities, build and maintain team capabilities to meet Quality Assurance needs
      • Set goals and objectives for the department and define Key Performance Indicators
      • Manage and improve site Quality Systems to facilitate the development and production of AAV gene therapies
      • Assists with the resolution of complex quality or compliance issues associated with process and analytical development
      • Manage the continued implementation of the LIMS system
      • Support VectorY colleagues to address technical issues and troubleshooting associated with the use of site Quality Systems
      • Lead the implementation of an electronic document management system
      • Coordinate QA document review or manufacturing and assay related documents
      • Provide QA support associated with laboratory operations to meet relevant regulatory requirements

Qualifications

  • Skills and Qualifications:

     

    • A Bachelor / Master degree in life science, biotechnology or related subject with a minimum of 5 years of QA experience, preferably in the biotech or pharmaceutical industry.
    • Experience leading Quality Assurance and QMS activities, some line management experience preferred
    • Experience with LIMS and QMS systems, ideally LabVantage and Simploud
    • Proficient in the English language verbally and in writing
    • Knowledge of QA requirements for pharmaceutical manufacturing
    • Proficient in MS Word, Excel, Power Point, Outlook, Teams

    Your Natural Strengths and Drivers

    • Ability to manage QA projects independently with proven problem-solving skills
    • Interest and experience implementing new systems and procedures
    • Good verbal and written communication skills in Dutch and English in word and writing.
    • Ability to work in a fast paced, rapidly changing environment, proactive attitude, optimization, can do mentality.

     

    Working at VectorY

     

    We offer a personal and authentic experience within a young, ambitious biotech company on the path to bring innovative therapies to patients worldwide.

Interested? Apply directly!

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