Senior Quality Audit Specialist

2 weeks ago

Dublin, Ireland AstraZeneca GmbH Full time

Overview

*ROLE CAN BE BASED FROM ATHLONE, CORK OR DUBLIN OFFICES*

Are you ready to make a significant impact in the realm of rare diseases? As a Senior Quality Audit Specialist, you'll be at the heart of AstraZeneca's Global Quality Audit team, working within the Alexion Rare Disease Unit. Your role will be pivotal in managing the audit and inspection processes from start to finish, ensuring best practices are upheld and employees are well-versed in audit management systems. Dive into a role where your expertise will guide key stakeholders and drive continuous compliance improvements.

Accountabilities

- Deliver quality assurance activities at Alexion's GQA hub to support audits and health authority inspections.
- Guide stakeholders during audit/inspection preparation and management.
- Develop and communicate audit schedules/plans.
- Create audit agendas by identifying risks/issues and engaging stakeholders.
- Review and issue audit reports.
- Manage report/response entry into the Quality Management system.
- Oversee audit actions from receipt to closure.
- Review and report quality system metrics.
- Support audit readiness, hosting, and reporting tasks during audits/inspections.
- Oversee outsourced activities from assignment to delivery.
- Lead audit consultancy communications for program management.
- Work independently and collaboratively as an individual contributor.
- Partner with stakeholders to collect feedback for effective audit function operation.
- Act as a quality contact for audit/inspection queries.
- Lead continuous compliance improvement projects.
- Review and approve SOPs and procedural documentation.
- Serve as SME/Quality contact on key Quality system records.
- Support/lead audits when required.

Essential Skills/Experience

- Bachelor's Degree in physical/life science or pharmacy; Advanced degree preferable
- Minimum of 5 years’ experience in a GxP Quality Assurance or Compliance Management related role, with Quality Management Systems knowledge
- Demonstrable communication and project management skills; experience working in cross-functional teams
- Strong Business Partner with a focus on collaboration and delivering results
- Knowledge of applicable international GXP regulations and standards (e.g., GMP, GDP etc.)
- Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written
- Experience with Quality Systems/tools (e.g. Microsoft office, ECMS, EQV, SmartSheet) an advantage

Desirable Skills/Experience

- Exposure to audits (internal, supplier or corporate) or inspectorates (e.g. HPRA, FDA, NSAI) is an advantage
- Exposure to supplier quality management

Date Posted 25-Sep-2025

Closing Date 08-Oct-2025

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.

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