Director Quality GCP

Job Purpose

As the Director Quality GCP, you will lead a team of GCP Quality staff, evolve and execute the GCP Quality strategy and related oversight activities supporting MoonLake’s clinical programs up to and including Phase 3 and into commercial operation.
Key accountabilities:

• As part of the MoonLake Quality Team, in consultation with the Associate VP Quality, The Quality Team, Key stakeholders, and using available resources:
  • Identify and implement GCP Quality oversight requirements within MoonLake and our vendors.
  • Define and implement MoonLake GCP Quality strategy in alignment with the key internal stakeholders and ensuring the legal standards. Define the strategy to provide the necessary oversight.
  • Identify necessary resources to execute the plan, including recruitment of new team members and appropriate external resources (e.g. consultants).
  • Lead the GCP Quality team as it executes t...