Vacancy EU Qualified Person / Manager QA – Utrecht


Organization

For a global organisation in the pharmaceutical market that focuses on, among other things, cell therapy, we are looking for an EU Qualified Person / Manager QA.

Function

In this position as EU Qualified Person / Manager QA you are responsible for the release of clinical and/or commercial batches of cell therapy-based products. You have full authority to make decisions regarding product quality, safety, purity and efficacy, independent of other business interests. In this role you will support the implementation, organisation, management and execution of the quality assurance function and the quality management system.

Activities:

  • Interpret and apply international, regional and local regulations within the GMP/GDP environment and batch processing in the EU
  • Build an in-depth understanding of CAR-T cells and cell therapy-based processes, technology and the specific treatments intended to be commercialised
  • Interaction with global surveillance, location and supplier surveillance
  • Quality and supply chain functions to ensure compliant, efficient and timely batch processing for cell therapies
  • Participate in GMP or GDP-related health authority inspections as needed, respond to all noted observations and ensure implementation of corrective actions
  • Managing quality and compliance risks by performing risk assessments and ensuring mitigation actions are taken
  • Participate in optimising a delivery process that takes into account the specificities of phased-release autologous cell therapy treatments, treatment of OOS results and related risk assessments
  • Conduct final review and approval of non-routine quality investigations related to batch variances, batch disposition and other quality systems for assigned products
  • Identify and recommend product and process quality improvements
  • Provide overview in statistics and view monthly variances, CAPA, batch release lead times, etc.
  • Support and maintain and continuously improve the quality management system
  • If necessary, draw up and/or revise procedures, work instructions and standards
  • Act as a deputy for EU QP
  • Draft or review, negotiate with contractors and recommend approval for quality agreements
  • Participate in GMP audits of suppliers and service providers when required

Requirements

You are the ideal candidate if you meet the following requirements:

  • You have at least 5-10 years of demonstrable work experience in the biotechnology industry
  • You have completed an MSc degree and/or PhD in a technical or scientific direction
  • You have experience and good knowledge of aseptic manufacturing, biological products and/or advanced therapy drugs, especially CAR-T cells
  • You have in-depth knowledge of pharmaceutical production, packaging, testing and distribution processes and associated global regulatory GMP / GDP requirements (especially EU)
  • You have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team-oriented approach
  • You have excellent organisational, project management and problem-solving skills
  • You understand processes and interactions that are essential for ensuring and enforcing regulatory compliance

Offer

This organisation can offer you the following:

  • Salary between €80,000.- – €100,000.- based on knowledge and experience
  • A bonus between 10 and 15%
  • A car allowance
  • Excellent pension
  • Good secondary employment conditions

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Romy Snijder
Associate | Biotech/Pharma division

+31 6 58 81 46 32
+31 23 754 86 60
r.snijder@qtcrecruitment.com