Senior Specialist QA

Alexion; Athlone; On-site; EUR 105,000 - 120,000; Full time

Job summary

Alexion seeks a senior QA professional to lead quality assurance for Irish sites, ensuring products meet cGMP and regulatory requirements. You will partner with Manufacturing, QC, Engineering, and planning teams to ensure timely batch release and continuous improvement.

You will drive investigations, CAPA programs, and NPIs, overseeing validation and QA reviews while maintaining audit readiness and communication with regulators.

Qualifications

• A minimum of 7 years relevant pharma experience.
• BSc in science/pharmacy or equivalent education and experience.
• Strong knowledge of cGMP requirements for manufacturing/packaging.
• Experience with GMP management and regulatory agencies.
• Experience with New Product Introduction.

Responsibilities

• Quality leadership for Irish sites, ensuring compliance and supply.
• Review and approve SOPs, master batch records, validation materials.
• Lead investigations, root-cause analysis, CAPA implementation.
• Support technology transfers and NPIs for compliant rollout.
• Oversee validation QA review and release activities.
• Coordinate regulatory documentation and site inspections.
• Sustain audit readiness and support regulatory inspections.
• Develop quality metrics and digital reporting for improvement.

Skills

QA Leadership

cGMP Compliance

TrackWise

Regulatory Inspection

Education

B.Sc. in science/pharmacy

Tools

GxP tools

Job description

Introduction to role

Are you ready to safeguard the quality of life-changing medicines and keep patient supply flowing without compromise? Do you thrive at the intersection of compliance, investigation, and continuous improvement, turning complexity into clear, timely decisions that matter?

In this role, you will anchor quality assurance across our Irish manufacturing sites, ensuring clinical and commercial products meet cGMP, corporate, and regulatory requirements. You will be the quality point person for cross-functional teams, partnering with Manufacturing, QC, Engineering, Planning and QPs to deliver right-first-time outcomes and reliable batch release. Your work will protect product safety, quality and efficacy—and by extension, support patients who rely on our medicines and the continuity of our global markets.

Accountabilities

• Quality Leadership for Irish Sites: Provide technical expertise on QA and compliance to safeguard product quality and secure uninterrupted supply.
• GMP Documentation and Batch Review: Maintain and execute schedules for the timely review and approval of SOPs, master batch records, validation materials, and policies aligned to clinical and commercial needs.
• Deviation and CAPA Excellence: Lead and support investigations, apply root cause analysis, and implement risk-proportionate CAPAs that prevent recurrence and strengthen systems.
• Technology Transfer and New Product Introduction: Support transfers and NPIs to ensure compliant, validated, and inspection-ready implementation.
• Validation Oversight: Deliver QA review and approval of validation protocols and reports; provide independent quality oversight of validation activities.
• QP Release Support: Collaborate to maintain the product release schedule and ensure all quality prerequisites for certification are met.
• Regulatory Interface: Coordinate referrals of regulatory documentation (dossiers, site impact assessments, annual reports, QP declarations) and market-specific materials for site accreditations and product reviews.
• Audit Readiness and Inspections: Proactively sustain audit readiness and actively support internal audits and regulatory agency inspections.
• Digital Quality Metrics: Analyse data and develop reports on quality metrics and KPIs using digital tools; translate insights into targeted improvement actions.
• GxP Advice and Training: Provide site-wide GxP guidance; plan and support quality training for internal and external stakeholders.
• Coaching and Team Development: Guide early-career team members on quality processes, digital tools, and compliance requirements.
• Cross-Functional Partnering: Act as the quality point person, enabling fast, informed decisions with Manufacturing, QC, Engineering, Site Services and Planning to optimize patient supply.
• Continuous Improvement and Risk: Benchmark internal and external QA practices to identify and embed more efficient and effective approaches; drive risk assessments and process improvements.
• Management Delegation: Act as delegate for QA management as required to ensure continuity of leadership and decision-making.

Essential Skills/Experience

• A minimum of 7 years relevant experience within the pharma industry or a related field.
• Third level qualification (e.g., B.Sc. in science/pharmacy) with a minimum of 7 years’ experience in a cGMP Quality environment; or an equivalent combination of education and experience.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging.
• Direct experience of GMP management within a pharma/biopharma company, including exposure to FDA, HPRA/EMA or authorities of similar standing.
• Direct experience of New Product Introduction.
• Experience with quality processes across multiple areas.
• Experience interpreting and guiding team members around principles and concepts of compliance management within a regulated environment.
• Experience troubleshooting issues across quality areas.
• Experience implementing newer digital tools and technologies related to QA reporting, documentation, and analysis.
• Good knowledge of relevant computer packages (e.g., TrackWise or similar).
• Planning and organizing skills to plan, execute and track Quality Assurance commitments and adjust to changing priorities.
• High level technical skills including analytical, auditing, pharmaceutical manufacturing, and regulatory inspection management; technical writing skills.
• Excellent accuracy and attention to detail.
• Excellent interpersonal skills with strong verbal and written communication, and the ability to represent company interests, objectives and policies in a responsible and professional manner.
• Demonstrated mature leadership and interpersonal influencing skills.
• Advanced problem-solving skills with proven ability to independently analyze complex issues, identify root causes, develop effective solutions, and lead or participate in high‑risk investigations using critical thinking and sound judgment.

Desirable Skills/Experience

• Experience of sterility assurance for drug products and in pharmaceutical manufacturing processes.
• Experience conducting data analysis and generating insights on quality metrics and KPIs using digital tools and processes.
• Experience coordinating regulatory documentation such as dossiers, site impact assessments, annual reports, or QP declarations.
• Experience benchmarking internal and external quality assurance practices to identify and apply innovative, efficient approaches.

Why AstraZeneca

Join a team dedicated to transforming the lives of people with rare and devastating diseases, where your expertise directly shapes the safety and availability of our medicines. We combine the agility and ownership of a biotech environment with the scale and investment of a global science-led organization. You will work alongside curious, generous colleagues—scientists, engineers, QPs and operators—in the same room solving the same problem, turning patient needs into decisive quality actions. Expect tailored development, modern digital tools, and leaders who value kindness alongside ambition, so you can stretch your capabilities while staying grounded in what matters most: delivering for patients.

Date Posted

12-Aug-2026

Closing Date

25-Aug-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.