Global Head, Sterility Assurance & Contamination Control

Alexion Pharmaceuticals, Inc.; Dublin; Hybrid; EUR 180,000 - 280,000; Full time

Job summary

AstraZeneca is seeking a senior leader to shape global sterility assurance and contamination control across a worldwide biopharma manufacturing network. You will embed sterility assurance within the Pharmaceutical Quality System, harmonizing standards and elevating technical excellence across Drug Substance, Drug Product and Combination Product manufacturing.

Reporting to senior QA leadership, you will drive contamination control, risk management and inspection readiness, building capability and

Qualifications

• Bachelor's degree in microbiology or related life science.
• 15+ years in sterility assurance, aseptic processing, contamination control or industrial microbiology in biopharma GMP.
• Proven leadership of an SA&CC function at scale; ability to mentor teams.
• Deep regulatory expertise in global aseptic processing and sterile drug regulations; SME in inspections.
• Broad knowledge of aseptic processing, cleanroom classification, HVAC, sterilisation, EM, APS and QRM.
• Experience leading investigations, root cause analysis and CAPA.
• Strong GMP experience and PQS, deviation, CAPA, change control, data integrity.
• Strong influencing skills across Quality and Technical Operations; global governance.
• Experience with external manufacturing partners and facility start-up.

Responsibilities

• Set and own global sterility assurance and contamination control strategy.
• Define CCS documents and review site CCS with QA.
• Establish network standards for aseptic design and operation.
• Own global APS strategy and media fills.
• Coordinate contamination events and lead complex investigations.
• Apply ICH Q9 tools and define SA&CC metrics.
• Ensure inspection readiness and regulatory submissions support.
• Drive NPI/Tech Transfer with contamination control by design.
• Innovate microbial methods and rapid detection with validation.
• Mentor microbiology and aseptic teams; build capability.

Skills

Leadership

Regulatory expertise

Quality systems

GMP compliance

Process knowledge

Microbiology methods

Investigations

Data integrity

Global governance

Cross-site leadership

Education

Bachelor's degree in microbiology or related life science

Job description

AstraZeneca is seeking a senior leader to shape global sterility assurance and contamination control across a worldwide biopharma manufacturing network. You will embed sterility assurance within the Pharmaceutical Quality System, harmonizing standards and elevating technical excellence across Drug Substance, Drug Product and Combination Product manufacturing.

Reporting to senior QA leadership, you will drive contamination control, risk management and inspection readiness, building capability and