QA Digital Manufacturing Lead

Job Details

• Industry: Pharma/Biotech/Clinical Research
• City: Limerick
• State/Province: Limerick
• Country: Ireland

Job Description

The QA Digital Manufacturing Lead provides QualityAssurance oversight and guidance for the implementation of digitalmanufacturing solutions within a pharma manufacturing environment. The rolefocuses on enabling review by exception (RBE), electronic batch records (eBR),and paperless operations, ensuring compliance with GMP, data integrity, andregulatory expectations while supporting operational efficiency.

Responsibilities

• Provide QA leadership and guidance for the design andimplementation of eBR and paperless manufacturing processes.
• Define and approve review by exception (RBE) strategies,including deviation thresholds, exception handling, and QA review models.
• Ensure digital manufacturing solutions are aligned withGMP, data integrity principles (ALCOA+), and applicable regulatory requirements(e.g., FDA, EU).
• Partner with Manufacturing, Automation, IT, and Qualityteams to embed quality-by-design into digital workflows.
• Review and approve quality requirements, riskassessments, and validation/CSA deliverables related to digital plant systems.
• Support inspection readiness by ensuring digitalprocesses are defensible, well-governed, and clearly documented.

Qualifications

• Strong QA background in pharmaceutical manufacturingunder GMP.
• Hands-on experience with eBR, DeltaV, MES, or digitalmanufacturing systems.
• Solid understanding of review by exception concepts andpaperless batch release.
• Ability to balance compliance, risk-based thinking, andoperational efficiency.