Quality Assurance Manager

CareerWise Recruitment; Limerick; On-site; EUR 90,000 - 110,000; Full time

Job summary

CareerWise Recruitment seeks a QA leader to drive digital manufacturing initiatives in pharmaceutical production in Ireland. You will steer eBR and paperless batch release programs, integrating GMP and data integrity principles.

Collaborating with Manufacturing, Automation, IT, and Quality teams, you will define review by exception strategies and ensure regulatory readiness. This role requires strong GMP QA background and hands-on experience with eBR, DeltaV, and MES.

Qualifications

• QA leadership experience in pharma manufacturing under GMP.
• Experience with eBR, DeltaV, MES or digital manufacturing systems.
• Understanding of review by exception concepts and paperless batch release.
• Ability to balance compliance, risk-based thinking, and operational efficiency.

Responsibilities

• Provide QA leadership and guidance for design and implementation of eBR and paperless manufacturing processes.
• Define and approve review by exception strategies, including deviation thresholds, exception handling, and QA review models.
• Ensure digital manufacturing solutions align with GMP, data integrity principles (ALCOA+), and regulatory requirements (FDA, EU).
• Partner with Manufacturing, Automation, IT, and Quality teams to embed quality-by-design into digital workflows.
• Review and approve quality requirements, risk assessments, and validation/CSA deliverables related to digital plant systems.
• Support inspection readiness by ensuring digital processes are defensible, well-governed, and clearly documented.

Skills

QA leadership

GMP

eBR

DeltaV

MES

Digital manufacturing systems

Review by exception concepts

Job description

• Provide QA leadership and guidance for the design and implementation 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 with GMP, data integrity principles (ALCOA+), and applicable regulatory requirements (e.g., FDA, EU).
• Partner with Manufacturing, Automation, IT, and Quality teams to embed quality-by-design into digital workflows.
• Review and approve quality requirements, risk assessments, and validation/CSA deliverables related to digital plant systems.
• Support inspection readiness by ensuring digital processes are defensible, well-governed, and clearly documented.

REQUIREMENTS:

• Strong QA background in pharmaceutical manufacturing under GMP.
• Hands-on experience with eBR, DeltaV, MES, or digital manufacturing systems.
• Solid understanding of review by exception concepts and paperless batch release.
• Ability to balance compliance, risk-based thinking, and operational efficiency.