Director of Quality and Performance

2 weeks ago

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

The Director of Quality and Performance will be responsible for leading all quality functions across the EU and US. This individual will lead the implementation of global quality control policies and procedures within the UK & US, ensuring alignment with the company's commercial and clinical goals and regulatory requirements.

Key Responsibilities
  • Lead a high-performing team, continuously improving team efficiency through effective management methods, such as fair and objective performance evaluation of team members and effective internal communication.
  • Ensure successful relationships across cross-functional departments and external partners engaged in the testing and release of raw materials, critical excipients, in-process, finished products, and stability samples.
  • Provide quality control support and oversight for clinical manufacturing and commercial activities, ensuring product quality and compliance with regulatory requirements.
Requirements
  • A scientific, engineering, or other related degree.
  • 10+ years of related experience with 7+ in a management role.
  • Relevant experience in a production environment within a laboratory and quality compliance roles within 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.
  • Knowledge of FDA, EMA, CFDA, PDA regulations, good data and documentation practices (GDDP), and application of current good manufacturing practices (cGMP).

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