External QA Manager, External Quality Operations Blanchardstown Road North, Dublin, Ireland QAQA - Quality Assurance

Alexion Pharma Spain S.L.; Dublin; Híbrido; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Alexion is seeking an External QA Manager to oversee external quality operations from our Dublin site. The role focuses on QA oversight of CMOs, review of batch documentation, CAPAs and change controls to ensure product safety, quality and regulatory compliance.

The position emphasizes collaboration with cross-functional teams and the use of AI tools to boost efficiency. The candidate will work in a cGMP environment, review SOPs and master batch records, and support continuous improvement

Qualificações

• Minimum degree in Biological Sciences, Chemistry, Microbiology or Pharmacy.
• 5+ years of quality experience, preferably with CMOs.
• Strong understanding of GxP and regulatory expectations.

Responsabilidades

• Quality oversight of CMOs manufacturing drug products for Alexion.
• Authoring, review and approval of QA-related procedures and batch documentation.
• Review of deviations, CAPAs, and change controls; maintain data integrity.
• Collaborate with cross-functional teams to ensure cGMP compliance.
• Utilize approved AI technologies to support analysis and risk assessment.

Conhecimentos

QA oversight

cGMP knowledge

CAPA tracking

Cross-functional leadership

AI in QA

Formação académica

B.A./B.Sc. in Biological Sciences, Chemistry, Microbiology or Pharmacy

Ferramentas

LIMS

SOP authoring tools

Descrição da oferta de emprego

## External QA Manager, External Quality OperationsBlanchardstown Road North, Dublin, IrelandApply NowFind out how well you match with this job**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-2026Our 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.