Regulatory Quality Assurance Manager

2 days ago


Copenhagen, Copenhagen, Denmark AGC Inc Full time

Regulatory Quality Assurance Manager

We are seeking an experienced Regulatory Quality Assurance Manager to join our team in QC General Analytics. The successful candidate will have a strong background in regulatory affairs and experience in quality assurance, method validations, and regulatory compliance.

The ideal candidate will be responsible for ensuring regulatory compliance, developing and implementing quality procedures, and supporting regulatory inspections and customer audits. They will also work closely with cross-functional teams to develop and implement process improvements.

To succeed in this role, you will need:

  • Experience in GMP environments and knowledge of relevant guidelines
  • A quality and structured mindset, with experience in writing and reviewing GMP documentation
  • Strong communication skills and a service-minded attitude
  • The ability to handle multiple tasks simultaneously in a busy environment

Our Commitment to Innovation

At AGC Biologics, we are committed to continuous innovation and technical creativity. We strive to solve our clients' most complex challenges and provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins.



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