External QA Manager, External Quality Operations

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

This is what you will do:

The QA Manager for external quality operations supports the QA activities as required by Alexion External Quality in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. Intern for external quality performs’ all responsibilities in accordance with company policies, procedures, and regulations.

You will be responsible for:

• Quality Overight of Contract Manufacturing Organisations (CMOs) manufacturing Drug product on Alexions behalf.
• Authoring, review and approval of QA-related procedures.
• Review of batch documentation.
• Tracking of quality management system activities including deviations, CAPAs and change controls.
• Perform all job functions in compliance with cGMPs and maintain accurate and legible records.
• Where required, maintain external quality metrics/key performance indicators ensuring site visibility and trending to support continuous improvement activities.
• Documentation review of SOPs, master batch records, policies, standards, validation protocols and reports as required.
• Other activities, as required to support the Alexion External Quality team and stakeholders.

You will need to have:

• This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.
• The person in this position will receive supervisory direction on all routine and non-routine activities. Routine activities will be unsupervised as training and competency develops. The person in this position must have good organizational skills and the ability to lead projects/ engage with cross functional stakeholders.
• The position requires the individual to work collaboratively with colleagues, peers and managers.
• A good understanding of the concepts and systems applied to cGMP operations is expected.
• Proficient in the use of approved AI technologies to support analysis, risk assessment, and operational efficiency. Able to critically review AI-generated outputs, maintain data integrity, and ensure compliance with GxP and regulatory expectations.

We would prefer for you to have:

• B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry , Microbiology or Pharmacy
• +5 years Quality experience, preferably experience working with CMO’s.

Date Posted

21-Oct-2026

Closing Date

03-Nov-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.