Head of Performance and Quality Management

2 weeks ago

London, Greater London, United Kingdom Elixir Associates Full time

About the Role:

We are seeking a highly experienced Head of Performance and Quality to lead our Quality Control Operations team across the EU and US.

Key Responsibilities:

  1. Develop and implement global quality control policies and procedures, ensuring alignment with commercial and clinical goals and regulatory requirements.
  2. Lead a high-performing team, improving efficiency through effective management methods, including performance evaluation and internal communication.
  3. Build and maintain successful relationships with cross-functional departments and external partners involved in testing and release of raw materials, critical excipients, in-process, finished products, and stability samples.
  4. 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 related degree.10+ years of related experience, with 7+ years in a management role.Relevant experience in a production environment within 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).

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