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Head of Performance and Quality Management

2 months ago

London, Greater London, United Kingdom Elixir Associates Full time

Job Summary:

The Head of Performance and Quality will be responsible for leading all Quality Control Functions across the EU and US. This role will oversee the implementation of global quality control policies and procedures within the UK & US, ensuring alignment with the company's Commercial/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 the 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 & commercial activities, ensuring product quality and compliance with regulatory requirements.

Requirements:

  • Relevant experience in a production environment within a Laboratory and Quality Compliance roles within a Biotechnology/GMP environment.
  • 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).

Education:

  • A scientific, engineering, or other related degree.

Experience:

  • 10+ years of related experience with 7+ in a management role.