Quality Assurance Manager (m/f/x)

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 Assurance Manager responsible for ensuring strict compliance with GMP and ISO 9001 standards across all production, laboratory, and computerized system processes, while fostering a culture focused on excellence and continuous improvement.

responsabilidades chave

• Ensure compliance with GMP, ISO 9001, and internal/external requirements while promoting process implementation and maintenance;
  
• Oversee critical document control (approval, revision, updates, distribution) and assist with regulatory filings and computerized documentation systems;
  
• Manage the complete lifecycle of records (identification, storage, protection, retrieval, retention time, and disposition);
  
• Comply with internal regulations and the company's code of conduct;
  
• Conduct internal audits to monitor systems, processes, and facilities;
  
• Represent and support the QA team during client and regulatory audits or inspections.
  
• Review batch records and manufacturing documents for product and process compliance;
  
• Review investigation reports for deviations, non-conformities, and customer complaints;
  
• Ensure products, processes, facilities, and systems conform to quality standards and regulations, assisting in reviewing procedures, specifications, and forms.
  
• Evaluate and approve qualification protocols/reports and cleaning procedures for facilities and equipment;
  
• Ensure annual validation and qualification plans for infrastructures, equipment, and processes are executed according to regulatory requirements.
  
• Support team members in daily tasks to maintain alignment with key objectives;
  
• Communicate actively across departments to identify continuous improvement opportunities;
  
• Promote QA best practices and foster a quality-oriented culture throughout the company.
  
  

  competências

  
  
  • Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related fields;
    
  • Typically requires 5 years of relevant experience within a Quality Assurance GMP environment within the Pharmaceutical Industry (mandatory);
    
  • Solid knowledge of Quality, GMPs, ICH and ISO guidelines, principles and practices;
    
  • Good communication skills (verbal and written);
    
  • Skilled at managing processes and tools;
    
  • Fluency in English;
    
  • Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down;
    
  • Strong team player with a collaborative mindset, highly empathetic and a natural willingness to share knowledge and insights;
    
  • A proactive attitude toward continuous improvement of QA processes, with the resilience to manage complex situations and turn them into learning opportunities.
    
    

    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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