QA Manager

Job description

About Gadeta

Gadeta is a clinical stage biotechnology company developing a first-in-class cellular immunotherapy for the treatment of cancer, using a number of proprietary manufacturing and T-cell engineering technologies. The Company is pioneering the development of αβ T-cells engineered to express defined γδ T-cell receptors that can specifically recognize cancer cells, eliminate them, and spare healthy cells. Gadeta has a pipeline of product candidates in development for the treatment of haematologic malignancies and solid tumours.


Role Summary

We are seeking a highly motivated and talented QA Manager to oversee all QA activities at our facility in the Life Science Incubator in Utrecht. The candidate will be the main point of contact for quality issues both internal and with external critical vendors, and will participate in cross departmental improvement projects.

If you would like to work in a fast-paced and dynamic environment, then this is the position for you.

Job requirements

Key Responsibilities

  • Design, implement, and improve company quality standards.
  • Maintain and improve QMS system
  • Manage and maintain the system for deviations, complaints and CAPA’s
  • Manage external deviations, complaints and CAPA’s that may occur at critical vendor sites externally.
  • Manage vendor selection, qualification and monitoring
  • Preparation and execution of internal audits and external vendor audits
  • (Participate in regulatory inspections as necessary)
  • Drafting work instructions and procedures
  • Advising other departments on quality related matters
  • Training employees

Demonstrated skills and competencies

Qualifications

  • Completed HBO education (life sciences) or a similar level through experience
  • Good command of the Dutch and English language, both verbally and written
  • At least 5 years of work experience in a QA role within the biotech/pharma industry

Experience

  • Experienced with quality systems including deviations, CAPAs and Change control
  • Some experience in developing a QMS system from early start-up to phase 3/commercial biotechnology company is preferred

Other

  • Knowledge of GMP / GCP
  • Excellent planning and organization skills
  • Excellent team player and communication skills
  • Good attention to detail and commitment to delivering high quality work
  • Ability to identify problems and implement solutions