QA Manager

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.

With R&D 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.

 

Short description of the position

The QA manager will build the VectorY quality management systems and QA team needed to bring our first product to the clinic. He/she will design the quality strategy and will be responsible for implementation in the company. The strategy will include policies & procedures to assure compliance of outsourced GMP manufacturing activities, preclinical toxicology studies and clinical trials. Strong leadership and managerial skills, with the ability to effectively lead cross-functional teams and collaborate with stakeholders are essential in this role.

 

Main responsibilities of the role

  • Develop and implement quality assurance policies and procedures.

  • Ensure compliance with regulatory standards and guidelines (FDA, EMA, ICH, etc.).

  • Lead and manage QA activities related to GMP, GLP, and GCP.

  • Lead the development and implementation of risk management strategies.

  • Oversee and conduct audits (internal, external, and vendor).

  • Collaborate with CMC, R&D and clinical teams to ensure quality in all phases of development.

  • Handle quality-related issues, CAPA management, and risk assessments.

  • Prepare for and lead regulatory inspections.

  • Stay updated on industry trends and regulatory changes.

  • Provide guidance and training to quality and cross-functional teams regarding quality principles, compliance requirements, and best practices in cell and gene therapy.

 

Skills and Qualifications:

  • Bachelor's or Master's degree in a relevant scientific discipline.

  • Minimum of 10 years experience in quality assurance within the pharmaceutical or biotechnology industry, preferably in gene therapy.

  • Strong understanding of GMP, GLP, GCP, and regulatory requirements.

  • Proven track record in a QA role during preclinical and clinical phases.

  • Excellent communication, leadership, and organizational skills.

Your Natural Strengths and Drivers

You are scientifically-driven, thorough, organized and have the ability to set priorities. We look for a team player with a get-things-done mentality. You work consistently in a fast-paced environment.

 

Working at VectorY

Challenging and varied work with a real impact. We offer a personal and authentic experience within a young, ambitious biotech company on the path to bring innovative therapies to patients worldwide. Interested? Please send your application to talent.acquisition@vectorytx.com to the attention of Sandra Lemmens.