Global Head of Sterility Assurance & Contamination Control

AstraZeneca

Dublin

On-site

EUR 120,000 - 180,000

Full time

3 days ago

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Job summary

AstraZeneca plc is seeking a senior leader to own global sterility assurance and contamination control strategy. You will harmonize standards across Drug Substance, Drug Product, and manufacturing sites and CDMOs, embedding sterility assurance within the PQS, and guiding site microbiologists through governance models to drive continuous improvement.

Reporting to the Executive Director of Technical Operations, you will transform environmental monitoring signals into proactive prevention and build

Qualifications

Bachelor-level or higher in microbiology or related life science with GMP exposure.
Experience leading sterility assurance or aseptic processing in biopharma environments.
Strong knowledge of regulatory expectations and CCS documentation.

Responsibilities

Set and own the global sterility assurance strategy and standards across sites and partners.
Define and oversee aseptic processing excellence, including validation, cleaning, and containment.
Lead contamination control strategy discussions, risk assessments, and remediation plans.
Drive data integrity and regulatory readiness for inspections and submissions.
Mentor site microbiology and aseptic teams, fostering prevention and continuous improvement.
Collaborate with QA, QC, and Site Quality leadership in a matrix governance model.