Quality
Quality Assurance Manager - Qualified Person

Glycostem is looking for an, energetic, proactive, precise and flexible team worker to support us as QA Manager. 

Full time position 

As QA Manager you will be responsible for managing a team of young and driven QA-professionals in a GMP environment on activities related to cell therapy. You will lead your team in maintaining a quality system for allogeneic cellular products in accordance with GMP and applicable international guidelines.  

The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role.  

If you have experience working as a QP it will be highly interesting in this position, you will serve as the Glycostem GMP expert and in this role you can make an important contribution to advancing this exciting new area of drug development. 

You must identify and resolving quality issues with appropriate supporting documentation and must provide relevant GMP support in and outside the QA department. You must be able to weigh the risk of the event and look for an efficient yet compliant solution. You are a people-oriented team leader, pro-active thinker, accurate, precise and constructively critical, experienced mentor and able to train staff on basic quality tasks. 

In this role you must implement procedures for attaining specific goals, objectives and receive guidance in terms of broad goals. Only the results of work are typically reviewed. 

Principal accountabilities of the QA Manager 
  • Manages all aspects of QA systems for a phase I to commercial GMP cell therapy manufacturing facility. 
  • Responsible for managing the QA department in a fast-growing environment (work planning, staffing and training, review and approval of batch/unit records). 
  • Consult with CEO on decisions to ensure alignment and agreement. 
  • Review and approve Glycostem SOPs, forms, protocols and reports. 
  • Review and approve Glycostem equipment qualifications. 
  • Ensuring changes are justified; procedures are followed and contain appropriate associated reference. 
  • Review and approve deviations, CAPAs and change controls within area of focus and partner with other departments on these topics as the Quality expert. 
  • Ensuring vendor management program is in place and support all Glycostem operations. 
  • The QA Manager is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP). 
  • As a QP perform final release of the pharmaceutical product for clinical use or manage contract QP(s). 
  • Involved in clinical shipments  
Qualifications 

The job as QA Manager will be held by a person with:  

  • MSC in science, biotechnology or related discipline with focus on cell biology and/or human cell culture technologies (stem cells, primary cells and/or tissue culture)  
  • 5 - 10 years’ experience with GMP certified industrial QC laboratory and or manafucturing 
  • 5 - 10 years’ of industrial experience with quality systems  
  • Good proficiency in English (work language) 
  • ATMP and or Biopharmaceutical experience would be preferred 
  • Preferably working as a registered QP  
  • Good knowledge of standard MS-Office product. 
Are you the one we are looking for? 

We offer a dynamic job with a lot of challenges, in which you can further develop your talents. You will work with small and passionate colleagues in an innovative organization. Besides this, you can count on: 

  • After a successful trial period a permanent contract is extended 
  • Competitive salary, after you first year your salary will be adjusted accordingly with your performance and dedication 
  • Pension premium contribution 
  • Travel allowance or public transport reimbursement 
  • 25 holidays 
  • Stock option plan 
Do you have what it takes? 

Please convince us by sending your motivation and CV in English to Liana van Genuchten (HR@Glycostem.com). Selected candidates will be invited for a face-to-face interview with the line management.  

Want to know more? 

E-mail our HR department at HR@Glycostem.com for more information about Glycostem and selection process. 

Recruiters should not contact us. 

Please be aware that your application means that the information you provide will be shared by and with HR and the employees who are involved with the procedure. In case the procedure with you ends, your application and provided information will be deleted within four weeks after the moment you have been informed. Your name and date of application will be registered in our database for statistical use and status only. By applying you agree with and have taken notice of these conditions.