Senior External Quality Lead - Biologics Transfers

AstraZeneca GmbH; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

AstraZeneca GmbH in Ireland is seeking a Quality Leader to drive successful technical transfers with CMOs, ensuring safe, compliant, and reliable outcomes that reach patients faster.

You will align critical process parameters, guide PPQ runs, and embed quality by design while coaching junior team members and supporting audits. This role requires collaboration across development, clinical supply, and external manufacturing to maintain inspection readiness and regulatory confidence.

Qualifications

• Bachelor's degree in biological/chemical sciences or related field.
• 5+ years of cgmp experience in biotech/pharma quality.
• QA oversight across end-to-end transfer activities incl. CPPs/CQAs.
• Understanding of bulk drug substance and drug product manufacturing.
• Experience with contract manufacturing and regulatory compliance.
• Able to interpret quality standards and drive CAPA and risk-based decisions.

Responsibilities

• Quality Leadership: act as the quality lead with PDCS, EM&O, and key stakeholders to ensure on-time delivery of technical transfer projects and robust GMP outcomes.
• GMP Oversight: oversee GMP systems for CMOs and External Supply Chain to maintain compliance for clinical and commercial supply.
• CMO Documentation Compliance: review contractor docs (batch records, deviations, change controls) for alignment and closure.
• GxP Guidance: provide pragmatic GxP advice aligned to guidelines and embed quality by design.
• SOP and Audit Support: approve SOPs and support audits and inspections to sustain readiness.
• Metrics and Continuous Improvement: develop quality metrics for transfers and drive process improvements.
• Transfer Performance Insight: trend quality aspects of tech transfers to measure KPIs and lead CAPA implementation.
• Deviation and Risk Management: review deviations, perform risk assessments, and track follow-up and reporting.
• QA Project Support: assist QA in projects and meetings with clear impact reporting.
• Coaching and Enablement: mentor junior team members on quality processes and tools.

Skills

Quality Leadership

GMP Compliance

QA Oversight

Regulatory Knowledge

Cross-functional Collaboration

Education

B.Sc. in Biological/Chemical Sciences

Job description

AstraZeneca GmbH in Ireland is seeking a Quality Leader to drive successful technical transfers with CMOs, ensuring safe, compliant, and reliable outcomes that reach patients faster.

You will align critical process parameters, guide PPQ runs, and embed quality by design while coaching junior team members and supporting audits. This role requires collaboration across development, clinical supply, and external manufacturing to maintain inspection readiness and regulatory confidence.