External QA Manager: CMO Quality & Compliance Lead

AstraZeneca plc; Dublin; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

AstraZeneca plc is seeking an QA Manager for external quality operations in Ireland to protect drug safety, quality and efficacy for patients. The role supports Alexion External Quality and ensures availability of correct, safe products while safeguarding the company’s global operations.

The position requires following SOPs, leading cross-functional projects, and applying cGMP knowledge with a focus on AI-assisted analysis and risk evaluation.

Qualifications

• Follows written SOPs and records work clearly and in real time.
• Strong organizational skills; ability to lead projects and engage stakeholders.
• Ability to collaborate across functions and with supervisors as needed.
• Understanding of cGMP operations and regulatory expectations.

Responsibilities

• Quality oversight of CMOs manufacturing drug products on AstraZeneca's behalf.
• Authoring, reviewing and approving QA-related procedures.
• Review of batch documentation to ensure quality and compliance.
• Track QA activities including deviations, CAPAs and change controls.
• Maintain accurate, legible records in compliance with cGMP.
• Monitor quality metrics and KPIs for external quality sites and drive improvements.
• Review SOPs, master batch records, policies and validation reports.
• Support the External Quality team and stakeholders as required.

Skills

SOP compliance

Attention to detail

Project leadership

Cross-functional collaboration

GxP knowledge

AI in QA

Education

Bachelor's degree in Biological Sciences, Chemistry, Microbiology or Pharmacy

Job description

AstraZeneca plc is seeking an QA Manager for external quality operations in Ireland to protect drug safety, quality and efficacy for patients. The role supports Alexion External Quality and ensures availability of correct, safe products while safeguarding the company’s global operations.

The position requires following SOPs, leading cross-functional projects, and applying cGMP knowledge with a focus on AI-assisted analysis and risk evaluation.