Senior Quality Lead, External Manufacturing & Tech Transfer

AstraZeneca; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

AstraZeneca Ireland is seeking a senior QA leader to drive quality and compliance across biologics tech transfers from development to clinical and commercial supply. You will align processes with GMP, guidance, and CAPA standards, working with external manufacturers and internal teams to ensure right-first-time outcomes.

The role emphasizes risk-based decision making, mentoring junior staff, and sustaining inspection readiness across CMOs and partner sites in a fast-paced, patient‑focused

Qualifications

• B.Sc. degree in a regulated biopharma field or equivalent experience.
• 5+ years in cGMP quality roles within biotech/pharma manufacturing.
• Experience overseeing end-to-end tech transfers, deviations and CAPA.

Responsibilities

• Quality lead for technical transfer projects with PDCS, EMO and CMOs.
• Oversee GMP systems and readiness for clinical and commercial supply.
• Review contractor documents and drive closure of deviations.
• Provide pragmatic GxP guidance aligned to current regulations.
• Approve SOPs and support audits/pre-approval inspections.
• Develop quality metrics and lead CAPA and continuous improvement.
• Coach junior staff on quality processes and compliance.

Skills

Quality leadership

GMP / cGMP

QA oversight

Risk management

Deviations & CAPA

Documentation review

Education

B.Sc. in biological/chemical sciences

Job description

AstraZeneca Ireland is seeking a senior QA leader to drive quality and compliance across biologics tech transfers from development to clinical and commercial supply. You will align processes with GMP, guidance, and CAPA standards, working with external manufacturers and internal teams to ensure right-first-time outcomes.

The role emphasizes risk-based decision making, mentoring junior staff, and sustaining inspection readiness across CMOs and partner sites in a fast-paced, patient‑focused