Senior External Quality Leader - Biologics Tech Transfers

Alexion Pharmaceuticals, Inc.; Dublin; On-site; EUR 105,000 - 140,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. seeks an experienced Quality leader to ensure safe, compliant tech transfer milestones from development to commercial supply.

You will guide CMOs through PPQ runs, align CPPs/CQAs, and drive robust GMP outcomes across external manufacturing networks. Ideal candidates have 5+ years in cGMP quality roles in biotech/pharma, with strong collaboration across PDCS, clinical supply, and external partners.

Qualifications

• B.Sc. in biological/chemical sciences or related field in regulated industry.
• ≥5 years of cGMP experience in biotech/pharma manufacturing.
• QA oversight of end‑to‑end technical transfers for biologics including CPPs/CQAs, deviations, CAPA, and change controls.
• Experience with contract manufacturing/lab organisations essential.

Responsibilities

• Lead as quality lead with PDCS, EMO and external partners to ensure on‑time technical transfer delivery and GMP outcomes.
• Oversee GMP systems used by CMOs and External Supply Chain to maintain compliance for clinical and commercial supply.
• Review contractor documents (batch records, deviations, change controls) and drive closure actions.
• Provide pragmatic GxP guidance and embed quality by design principles.
• Approve SOPs and controlled documents; support audits and inspections to ensure readiness.
• Develop and report quality metrics for transfer activities and drive risk‑based improvements.

Skills

Quality leadership

GMP oversight

QA compliance

Risk management

Cross-functional collaboration

Data‑driven decision making

Education

B.Sc. in biological/chemical sciences

Job description

Alexion Pharmaceuticals, Inc. seeks an experienced Quality leader to ensure safe, compliant tech transfer milestones from development to commercial supply.

You will guide CMOs through PPQ runs, align CPPs/CQAs, and drive robust GMP outcomes across external manufacturing networks. Ideal candidates have 5+ years in cGMP quality roles in biotech/pharma, with strong collaboration across PDCS, clinical supply, and external partners.