Our client is an innovative, fast-growing Contract Development and Manufacturing Organization (CDMO) specialized in the advancement of cell and gene therapies (ATMPs) and biologics. Partnering with global leaders across the biotechnology and pharmaceutical sectors, the company bridges the gap between cutting-edge research and successful clinical and commercial translation.

Our client is seeking a Quality Control Manager to oversee the operational and technical activities of their Quality Control laboratory. Reporting to the Head of Quality, you will lead technical decision-making and guide a team of specialists to maintain strict compliance in a fast-paced GMP environment.

responsabilidades chave

• Supervise routine and non-routine testing of starting materials, in-process samples, bulk, and finished biological products in compliance with SOPs and GMP standards;
  
• Oversee the implementation, optimization, and continuous update of QC procedures, inspection methods, and departmental SOPs;
  
• Review and approve analytical test data and reports, ensuring prompt identification and technical investigation of Out-of-Specification (OOS) results;
  
• Ensure full qualification, calibration, and preventative maintenance of laboratory premises, state-of-the-art equipment, and analytical instrumentation;
  
• Lead, mentor, and resource-plan for a high-performing QC team, establishing departmental KPIs aligned with business goals;
  
• Drive follow-up actions and timely resolution of findings from internal audits and external regulatory/client inspections.
  
  

  competências

  
  
  • Bachelor’s or Master’s degree in Biochemistry, Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline;
    
  • Minimum 6 years of hands-on Quality Control experience in an industrial pharmaceutical or biotechnology setting;
    
  • Minimum 2 years of proven supervisory or team leadership experience within a GMP industrial manufacturing environment;
    
  • Technical proficiency in analytical methods tailored for biologics/ATMPs, including multi-color Flow Cytometry, ELISA, cell-based potency assays, and multiplexing assays;
    
  • Solid experience in standard pharmacopeial testing (sterility, endotoxin, mycoplasma) and non-compendial assay development, optimization, and validation;
    
  • Practical application of GMP regulations, data integrity standards, and scientific rigor in OOS investigations and technical troubleshooting;
    
  • High autonomy, emotional maturity, decision-making under operational pressure, and strong interpersonal and mentoring abilities;
    
  • Full professional fluency in English (written and spoken).
    
    

    principais benefícios

    
    
    • Competitive salary package tailored to market standards and individual experience;
      
    • Opportunity to work in a high-impact, cutting-edge industry (Cell & Gene Therapy / Biologics);
      
    • Dynamic, collaborative, and scientifically rigorous environment with continuous learning and career advancement opportunities.
      
      

      Randstad is on a mission to become the world’s most equitable and specialized talent company; therefore, we welcome individuals with diverse abilities and experiences. We are committed to ensuring that our recruitment and hiring process meets everyone's needs.
      

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