Global Head of Sterility Assurance & Contamination Control

Alexion Pharma Spain S.L.; Dublin; Hybrid; EUR 170,000 - 230,000; Full time

Job summary

AstraZeneca in Dublin seeks a Head of Sterility Assurance and Contamination Control to partner with QA, QC and Site Quality leaders. You will guide microbiology and aseptic processing teams through a global governance model, building capability and ensuring rigorous scientific standards to drive continuous improvement.

You will define global strategies for CCS, aseptic processing, APS and incident investigations, lead regulatory readiness, and mentor the site teams to uphold GMP, data integrity

Qualifications

• Bachelor's degree in microbiology or a related life science; 15+ years in sterility assurance or related fields.
• Experience leading SA&CC functions in GMP environments with matrixed governance.
• Strong regulatory experience and capability to defend CCSs in inspections.

Responsibilities

• Set and own global sterility assurance strategy, standards, and KPIs across sites.
• Define contamination control strategy and review site CCS for compliance.
• Establish network standards for aseptic design, cleaning, qualification, and EM programs.
• Own APS strategy and standards for media fills.
• Coordinate contamination event responses, investigations and CAPA.
• Apply QA/QC regulatory intelligence and readiness for inspections.
• Mentor site microbiology and aseptic teams; build talent pipeline.
• Collaborate with Regulatory Affairs for submissions and responses.

Skills

Sterility assurance

Aseptic processing

Contamination control

Quality systems

GMP knowledge

Regulatory expertise

Leadership

Root cause analysis

Quality risk management

Technical operations

Education

Bachelor's degree in microbiology or life sciences

Master's degree or PhD in microbiology or related field

Job description

AstraZeneca in Dublin seeks a Head of Sterility Assurance and Contamination Control to partner with QA, QC and Site Quality leaders. You will guide microbiology and aseptic processing teams through a global governance model, building capability and ensuring rigorous scientific standards to drive continuous improvement.

You will define global strategies for CCS, aseptic processing, APS and incident investigations, lead regulatory readiness, and mentor the site teams to uphold GMP, data integrity