Senior Director, Quality Risk Management

Alexion-Pharmaceuticals-; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

AstraZeneca in Dublin is seeking a senior Quality Risk Management leader to embed risk-based thinking across operations and evolve the enterprise QRM process. You will ensure risk understanding and action across functions, safeguarding product quality and supply continuity for patients.

You will apply methodologies like FMEA, FMECA, FTA, HACCP, HAZOP, and PHA, and develop risk analytics dashboards to support Management Reviews and strategic decisions in a hybrid work setting.

Qualifications

• Bachelor-level degree in relevant field and GMP/GDP exposure.
• Experience with ICH Q9 and ISO risk guidelines; strong analytical skills.
• Ability to communicate complex risk to cross-functional audiences.

Responsibilities

• Partner with Operations to standardize risk practices in Ireland.
• Identify systemic gaps and develop remediation plans.
• Present risk metrics at Quality Management Review and customer forums.
• Represent QRM to GxP partners and lead risk discussions.
• Ensure QRM processes align with ICH Q9 and ISO guidelines; drive continuous improvement.

Skills

Quality Risk Mgmt

GxP Compliance

GMP/GDP

Risk Assessment

Cross-functional Collaboration

Education

Bachelor's degree in business management, engineering, or a scientific rigor

Tools

FMEA

FMECA

FTA

HACCP

HAZOP

PHA

Job description

AstraZeneca in Dublin is seeking a senior Quality Risk Management leader to embed risk-based thinking across operations and evolve the enterprise QRM process. You will ensure risk understanding and action across functions, safeguarding product quality and supply continuity for patients.

You will apply methodologies like FMEA, FMECA, FTA, HACCP, HAZOP, and PHA, and develop risk analytics dashboards to support Management Reviews and strategic decisions in a hybrid work setting.