Quality Assurance Associate Director for Quality Control

12 hours ago


Princeton, New Jersey, United States Galapagos Full time
Job Summary

We are seeking a highly experienced Quality Assurance Associate Director to lead our Quality Control operations in the US. As a key member of our team, you will be responsible for ensuring the highest standards of quality, compliance, and regulatory adherence in our Quality Control activities.

Key Responsibilities
  • Lead Quality Management System (QMS) applicable to QC in compliance with relevant regulations and standards.
  • Oversee clinical and commercial sample management.
  • Conduct QA reviews of QC release testing records.
  • Implement risk management strategies to identify, assess, and mitigate quality risks in ATMP QC processes.
  • Provide oversight for QMS QC records, ensuring accuracy, completeness, and traceability.
Requirements
  • Bachelor's degree in a relevant field.
  • Minimum of 8 years of experience in a GMP environment with comprehensive knowledge of cGMP QA or QC processes.
  • Proven experience in a commercial GMP manufacturing setting.
  • Strong interpersonal skills and the ability to present work effectively in various settings.
  • Proven ability to collaborate proactively and manage projects efficiently.
What We Offer

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.



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