Director of Analytical Operations

5 days ago


Ennis, Clare, Ireland Meiragtx Ireland Dac Full time

Job Overview:

We are seeking an experienced Senior Qc Analytics Manager to lead our Quality Control (QC) team in ensuring the laboratory is inspection ready and that any data generated is valid and in compliance with applicable internal and external cGMP requirements.

Responsibilities:

  • Lead the Quality Control (QC) team in managing day-to-day operations
  • Oversee the Quality Control department to ensure compliance with EU and US GMP requirements
  • Provide line management to members of the QC analytical team
  • Develop and manage the site testing schedule
  • Plan and assign work to the team to achieve efficient use of personnel and resources
  • Responsible for running and maintaining the QC lab(s) to GMP compliance
  • Manage the stability programme
  • Support incoming material testing
  • Ensure all quality events investigated and closed in timely manner

Key Skills and Qualifications:

  • 7+ years working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site
  • Experience of managing a team people within a cGMP QC analytical environment
  • Degree in a relevant scientific discipline or equivalent experience
  • Understanding of GMP requirements
  • Good Collaboration, Communication and Conflict resolution skills
  • Experience in audit inspections
  • Good technical writing skills


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