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Director of Quality Assurance

2 months ago

London Area, United Kingdom Elixir Associates Full time
About the Role

Elixir Associates is a leading partner in the biotech industry, collaborating with innovative companies to develop groundbreaking therapies for oncology and autoimmune diseases.

We are seeking a highly experienced and skilled professional to lead our Quality Control Operations across the EU and US.

Key Responsibilities
  • Implement and maintain global quality control policies and procedures, ensuring alignment with commercial and clinical goals, as well as regulatory requirements.
  • Lead a high-performing team, providing coaching and mentorship to ensure continuous improvement and effective management.
  • Develop and maintain successful relationships with cross-functional departments and external partners, ensuring the testing and release of raw materials, critical excipients, and finished products.
  • Provide quality control support and oversight for clinical manufacturing and commercial activities, ensuring product quality and compliance with regulatory requirements.
Requirements
  • Scientific, engineering, or related degree
  • 10+ years of related experience, with 7+ years in a management role
  • Relevant experience in a production environment, with a focus on laboratory and quality compliance roles in a biotechnology/GMP environment
  • Experience and understanding of vaccines, oncolytic viruses, or cell and gene therapies
  • In-depth knowledge of industry standards and regulations related to quality control, including FDA, EMA, CFDA, PDA regulations, and good data and documentation practices