External Quality Lead, Biologics Tech Transfer

Alexion Pharma Spain S.L.; Dublin; Hybrid; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Travel opportunities

Job summary

AstraZeneca is seeking a Quality Leader to drive safe, compliant tech transfer milestones with contract partners, ensuring right-first-time manufacturing and robust GMP outcomes. You will guide CMOs through engineering/PPQ runs, align CPPs/CQAs, and translate data into sustainable process improvements.

You will collaborate with PDCS, EMO, and external vendors to maintain inspection readiness and regulatory confidence while mentoring junior team members on quality processes and compliance

Qualifications

• Bachelor-level degree in biological/chemical sciences or equivalent in regulated industry.
• 5+ years cGMP experience in biotech/pharma manufacturing, from pre-clinical to tech transfer.
• Experience with QA oversight of end-to-end biologics transfers and PPQ runs.

Responsibilities

• Lead quality for technical transfer projects with PDCS, EMO, and CMOs to ensure on-time delivery and GMP readiness.
• Oversee GMP systems executed by CMOs and External Supply Chain for Drug Substance/Product.
• Review contractor documents, including batch records, deviations, and change controls; drive closure.

Skills

Quality leadership

GxP expertise

Regulatory knowledge

Cross-functional collaboration

Risk assessment

Education

BSc in biological/chemical sciences

Tools

GMP documentation systems

QA oversight across tech transfers

Job description

AstraZeneca is seeking a Quality Leader to drive safe, compliant tech transfer milestones with contract partners, ensuring right-first-time manufacturing and robust GMP outcomes. You will guide CMOs through engineering/PPQ runs, align CPPs/CQAs, and translate data into sustainable process improvements.

You will collaborate with PDCS, EMO, and external vendors to maintain inspection readiness and regulatory confidence while mentoring junior team members on quality processes and compliance