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GMP Compliance Manager

1 week ago

Ottawa, Ontario, Canada MoonLake Immunotherapeutics Full time
Job Description

The GMP Compliance Manager will be responsible for ensuring that all aspects of our manufacturing operations comply with Good Manufacturing Practice (GMP) regulations. This individual will work closely with cross-functional teams to identify and mitigate potential risks, implement corrective actions, and maintain compliance with regulatory requirements.

Key Accountabilities
  • Develop and implement quality assurance procedures to ensure compliance with regulatory requirements.
  • Conduct regular audits and assessments to identify areas for improvement.
  • Collaborate effectively with the Senior Manager Device Quality to ensure compliance of contractors for manufacture and testing of DP-device combination products.
  • Provide training and support to colleagues on quality-related matters.
Requirements
  • A scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry, or related).
  • Some experience of working in Quality functions in a pharmaceutical/biotech or device manufacturing environment, specifically in batch review/manufacturing oversight.
  • Strong analytical and problem-solving skills.
  • Ability to work proactively using own initiative within a matrix team structure.