GxP Quality Audit Lead – Hybrid, Inspection Readiness

QA Resources Ltd; Cork; Hybrid; EUR 85,000 - 120,000; Full time

Job summary

QA Resources Ltd in Ireland seeks a Quality Audit & Inspection Readiness lead on a 12-month initial contract, hybrid in East Cork. You will lead a risk-based internal audit programme and an site-wide inspection readiness strategy to ensure sustained GxP compliance and successful regulatory inspection outcomes.

Responsibilities include developing risk-based audit plans (7–10 audits per year), overseeing GMP, validation, data integrity audits, coaching SMEs, coordinating mock inspections with

Qualifications

• 8–12+ years' experience in pharmaceutical manufacturing, QA or compliance.
• Extensive experience leading and supporting regulatory inspections.
• Strong GMP, validation and data integrity expertise.
• Lean Six Sigma Black Belt qualification.

Responsibilities

• Audit Leadership: develop and execute a risk-based internal audit plan and oversee high-risk audits.
• Inspection Readiness: own and lead site inspection readiness strategy and mock inspections.
• SME Coaching: design and deliver GMP inspection readiness training and coach SMEs.
• Regulatory Oversight: review audit responses, CAPA plans and regulatory responses.
• Data-Driven Risk: oversee analytics-driven audit planning and trend quality metrics.
• Process Design: design, standardise and deploy internal audit and inspection processes.

Skills

Audit leadership

Data-driven risk

Stakeholder engagement

Regulatory inspections

GxP compliance

Data integrity

GMP expertise

Lean Six Sigma Black Belt

Education

Science degree

Pharmacy degree

Engineering degree

Job description

QA Resources Ltd in Ireland seeks a Quality Audit & Inspection Readiness lead on a 12-month initial contract, hybrid in East Cork. You will lead a risk-based internal audit programme and an site-wide inspection readiness strategy to ensure sustained GxP compliance and successful regulatory inspection outcomes.

Responsibilities include developing risk-based audit plans (7–10 audits per year), overseeing GMP, validation, data integrity audits, coaching SMEs, coordinating mock inspections with