Site Sterility Lead, Associate Director - Dundalk

539

Dundalk, Ireland
**
Bachelor's degree in microbiology
10+ years biopharma experience
Eu gmp annex 1 expertise
** This job posting is for an Associate Director, Site Sterility Lead at a biopharma company in Dundalk, Ireland, focusing on improving aseptic standards and influencing sterile product manufacturing. The role requires extensive experience in microbiology and contamination control within a pharmaceutical context, as well as leadership capabilities in a hybrid work environment. **

Job Summary

  • This role offers a high-impact opportunity to shape aseptic standards and mentor operations personnel within a dynamic, multi-product vaccine facility.
  • The successful candidate will serve as the Subject Matter Expert for site sterility assurance, ensuring alignment with EU GMP Annex 1 and cGMP requirements.
  • You will act as the site owner of the Environmental Monitoring Program, leading microbial-related investigations and driving site inspection readiness.

Matching Summary

Match Score: 75

** This job posting is for an Associate Director, Site Sterility Lead at a biopharma company in Dundalk, Ireland, focusing on improving aseptic standards and influencing sterile product manufacturing. The role requires extensive experience in microbiology and contamination control within a pharmaceutical context, as well as leadership capabilities in a hybrid work environment. **

Skills & Requirements

Must-have

  • Bachelor's degree in microbiology
  • 10+ years biopharma experience
  • EU GMP Annex 1 expertise
  • Environmental monitoring program ownership
  • Root cause analysis skills
  • Aseptic manufacturing knowledge

Nice-to-have

  • Strong written communication abilities
  • Mentoring operations personnel
  • Driving continuous improvement
  • Global audit inspection readiness
  • Microbiology best practices sharing

Key Requirements

  • Bachelor's degree in microbiology or relevant discipline
  • 10+ years experience in Biopharma/Pharma Industry
  • Expertise in Eudralex Annex 1 requirements
  • Proven experience in root cause analysis
  • Experience in technical appraisal and audits

Work Rights

Not specified

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