Senior Specialist, Quality Assurance

Location: Athlone, Ireland

Shift: 7 / 7 Shift

Week 1: 7pm – 7am (Mon, Tues, Sat, Sun)

Week 2: 7pm – 7am (Wed, Thurs, Fri)

Help bring life-changing medicines to patients

At Alexion, quality is at the heart of everything we do. We are looking for a Senior Specialist, Quality Assurance to provide frontline Quality Assurance leadership and support across our manufacturing operations in Athlone.

This is a highly visible, shift-based role where you will partner closely with Manufacturing, Quality Control, Engineering, Site Services, Planning, and Qualified Persons to ensure compliant, efficient, and uninterrupted product supply. As a trusted quality expert, you will provide real-time quality oversight, support critical decision-making on the production floor, and help ensure that every product released meets the highest standards of quality, safety, and compliance.

You will also play a key role in driving operational excellence, digital transformation, and continuous improvement initiatives that enhance quality performance and support patient supply.

What you'll do

As a Senior Specialist, Quality Assurance, you will:

• Provide quality leadership and technical expertise across manufacturing operations during your assigned shift.
• Deliver direct, on-floor QA oversight to ensure activities are performed in accordance with cGMP requirements, approved procedures, and the site Quality Management System.
• Act as the primary Quality Assurance contact during your shift, supporting timely quality decisions and escalation of critical issues.
• Support manufacturing teams through real-time quality guidance, issue resolution, and risk-based decision-making.
• Review manufacturing activities, documentation, investigations, and quality records to ensure compliance and quality standards are maintained.
• Partner with stakeholders across Manufacturing, QC, Engineering, Planning, Site Services, and Quality functions to support reliable product supply.
• Lead or support deviation investigations, root cause analysis activities, and the development of effective corrective and preventive actions (CAPAs).
• Review and approve GMP documentation, including SOPs, validation documentation, master batch records, policies, and quality reports.
• Provide quality oversight for validation, technology transfer, and new product introduction activities.
• Support Qualified Person (QP) batch release activities and regulatory compliance requirements.
• Contribute to inspection readiness activities and support internal, customer, and regulatory inspections.
• Coordinate quality priorities across manufacturing areas and ensure effective shift handovers.
• Drive continuous improvement initiatives that enhance compliance, efficiency, and right-first-time performance.
• Analyse quality data, identify emerging trends, and provide insights to support informed decision-making.
• Support the development and adoption of digital solutions, automation opportunities, and data-driven quality processes.
• Help evaluate and implement innovative technologies, including artificial intelligence and advanced analytics solutions, within a compliant GxP environment.
• Support training, coaching, and development activities across quality and manufacturing teams.
• Mentor and guide colleagues on quality systems, compliance expectations, and digital tools.
• Act as delegate for QA leadership colleagues when required.

Essential requirements

• Degree in Science, Pharmacy, Biotechnology, Engineering, or a related discipline, or equivalent relevant experience.
• Significant experience working within pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
• Strong understanding of cGMP requirements and Quality Management Systems.
• Experience providing quality oversight within manufacturing, packaging, validation, Quality Control, or related operations.
• Experience supporting investigations, deviation management, CAPAs, and risk assessments.
• Ability to make sound, risk-based decisions in a fast-paced operational environment.
• Strong analytical and problem-solving skills with the ability to manage complex quality issues.
• Excellent communication, collaboration, and stakeholder management skills.
• Ability to interpret regulatory requirements and apply them pragmatically within operational settings.
• Strong organisational skills with the ability to manage multiple priorities and changing business needs.
• Willingness and ability to work a designated shift pattern while supporting manufacturing operations.

Preferred experience

• Experience within sterile, aseptic, biological, or biopharmaceutical manufacturing environments.
• Involvement in regulatory inspections, audits, and health authority interactions.
• Experience supporting new product introductions, technology transfers, or validation programmes.
• Knowledge of quality management systems such as TrackWise or similar platforms.
• Experience using digital tools, reporting systems, data visualisation platforms, or analytics solutions to improve quality outcomes.
• Experience supporting digital transformation initiatives within a regulated environment.
• Familiarity with process improvement methodologies such as Lean, Six Sigma, or Operational Excellence frameworks.
• Experience evaluating or implementing AI-enabled or advanced analytics solutions within a GxP environment.

Join us and help ensure every product we deliver meets the highest standards of quality, safety, and patient impact.

Date Posted

Closing Date