QA & Compliance Leader – Radiopharmaceuticals GMP

Curium Pharma

Dublin

On-site

EUR 90,000 - 130,000

Full time

10 days ago
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Job summary

Curium Pharma in Ireland seeks a Site Quality Leader to ensure HPRA GMP compliance and to lead the QA/QC department. You will drive regulatory readiness, product release, and data integrity across the site.

The role requires QMS expertise and a track record of managing GMP facilities, with strong leadership and collaboration across functions to support PET/radiopharmaceutical products.

Qualifications

  • Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology (Desirable).
  • Qualified Person status required.
  • 5 years on an HPRA license (Desirable).
  • 5-10 years in QMS experience.
  • Extensive experience managing staff and GMP facilities.

Responsibilities

  • Lead and develop QA/QC teams and ensure GMP compliance.
  • Oversee product release, deviations, CAPAs and regulatory inspections.
  • Own and improve the site's QMS and validation State.
  • Coordinate recalls, deviations and pharmacovigilance interfaces when required.
  • Represent QA in site leadership meetings and drive continuous improvement.

Skills

Leadership
Quality management
Regulatory compliance
Strategic thinking
Business development

Education

Pharmacy/Science degree
Qualified Person
HPRA license experience
QMS experience 5-10 yrs
Staff management

Job description

Curium Pharma in Ireland seeks a Site Quality Leader to ensure HPRA GMP compliance and to lead the QA/QC department. You will drive regulatory readiness, product release, and data integrity across the site.

The role requires QMS expertise and a track record of managing GMP facilities, with strong leadership and collaboration across functions to support PET/radiopharmaceutical products.

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