External QA Manager: CMO Quality Oversight

Alexion Pharma Spain S.L.; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Alexion is seeking an External QA Manager to oversee external quality operations from our Dublin site. The role focuses on QA oversight of CMOs, review of batch documentation, CAPAs and change controls to ensure product safety, quality and regulatory compliance.

The position emphasizes collaboration with cross-functional teams and the use of AI tools to boost efficiency. The candidate will work in a cGMP environment, review SOPs and master batch records, and support continuous improvement

Qualifications

• Minimum degree in Biological Sciences, Chemistry, Microbiology or Pharmacy.
• 5+ years of quality experience, preferably with CMOs.
• Strong understanding of GxP and regulatory expectations.

Responsibilities

• Quality oversight of CMOs manufacturing drug products for Alexion.
• Authoring, review and approval of QA-related procedures and batch documentation.
• Review of deviations, CAPAs, and change controls; maintain data integrity.
• Collaborate with cross-functional teams to ensure cGMP compliance.
• Utilize approved AI technologies to support analysis and risk assessment.

Skills

QA oversight

cGMP knowledge

CAPA tracking

Cross-functional leadership

AI in QA

Education

B.A./B.Sc. in Biological Sciences, Chemistry, Microbiology or Pharmacy

Tools

LIMS

SOP authoring tools

Job description

Alexion is seeking an External QA Manager to oversee external quality operations from our Dublin site. The role focuses on QA oversight of CMOs, review of batch documentation, CAPAs and change controls to ensure product safety, quality and regulatory compliance.

The position emphasizes collaboration with cross-functional teams and the use of AI tools to boost efficiency. The candidate will work in a cGMP environment, review SOPs and master batch records, and support continuous improvement