Senior Specialist, Commercial Stability

Do you see patterns in stability data before others do? Are you ready to safeguard registered shelf-life and keep critical medicines available for patients worldwide through rigorous, insight-driven stability leadership?

Based in Dublin, you will join a global function that owns the Commercial Stability Programme for marketed products and late-stage candidates transitioning to launch. Your decisions—what batches to enroll, how to design for-cause and transfer studies, which signals matter—will translate directly into product availability, regulatory confidence and business continuity. You will work at the center of cross-functional teams, partnering with manufacturing sites and technical leaders to meet post-approval commitments and uphold the highest standards of compliance.

This role is a chance to lead from the data: to define protocols, present performance at governance forums, navigate inspections as the stability SME, and embed continuous improvement that strengthens our end-to-end quality system. You will also mentor colleagues, amplify best practices, and act as delegate for the programme lead when needed—expanding your influence as you deliver measurable outcomes.

Accountabilities:
- Annual Stability Commitments: Identify and select commitment batches in line with post-approval obligations; issue and track sample requests with manufacturing sites.
- Study Design and Readiness: Engage with technical and project teams to define PPQ, technical transfer and for-cause stability studies; track relevant batches prior to enrolment.
- Programme Oversight: Enrol and manage stability studies across internally and externally managed products; ensure governance and control throughout lifecycle.
- Protocols and Reporting: Write, review and approve stability protocols, investigation reports, statistical assessments and associated documentation.
- Performance Metrics: Prepare and present stability programme performance at the Stability Review Board (SRB); drive transparency and action.
- Data Analytics and Risk Assessment: Interpret data trends and statistical analyses to determine risk to registered shelf-life; recommend mitigations and escalation where needed.
- Investigations and CAPA: Lead and manage investigations related to stability; define, implement and verify effective CAPAs.
- Change Management: Execute change activities in accordance with procedures; ensure robust documentation and traceability.
- Inspection Readiness: Serve as the stability subject matter expert during Health Authority inspections; represent programme strategy and data with clarity and rigor.
- Continuous Improvement: Identify and implement improvements that optimize the Commercial Stability Programme and adjacent Quality Operations processes.
- Leadership and Coaching: Mentor and train Stability Specialists, Stability Analysts and stakeholders to elevate capability and consistency.
- Delegation and Representation: Act as representative or delegate of the Commercial Stability Manager when assigned, including project team participation and coverage.
- Quality Operations Contribution: Support broader Quality Operations activities as business priorities require.

Essential Skills/Experience:
- Degree in chemistry or biological science (preference for Analytical Chemistry or Biochemistry) with a minimum of 5 years’ experience in a related role within the Pharmaceutical/Biotechnology industry.
- Previous hands-on experience managing stability programmes in a GMP environment; advanced knowledge of key stability guidelines.
- Conducts work in compliance with cGMPs, ICH guidelines and safety and regulatory requirements.
- Subject Matter Expert for stability processes and programme management.
- Excellent communication, interpersonal and organizational skills; able to work independently and in a team environment with minimal supervision.
- Ability to prioritise and deprioritise effectively in alignment with core business objectives.
- Computer skills with MS Office, including MS Excel and MS Project or comparable applications.
- Demonstrated ability to use AI tools to support data review and trend analysis, including understanding statistics to verify AI output data.
- Ability to use AI tools to support technical writing (risk assessments, LIRS, deviations) while understanding compliance boundaries.

Desirable Skills/Experience:
- Experience in the use of Electronic Document Management Systems and Quality Management Systems.
- Experience presenting stability programme performance at governance forums (e.g., SRB) and acting as stability SME during Health Authority inspections.
- Proven track record leading investigations and implementing effective CAPAs.
- Experience mentoring and training stability stakeholders across functions and sites.
- Exposure to PPQ, technical transfer and for-cause study design in commercial or late-stage environments.
- Change management experience within a regulated quality system.

Why AstraZeneca:
Join a team focused on rare diseases where technical excellence meets real-world impact for some of the most under-served patients. You will work with cutting-edge science and data alongside colleagues who bring diverse perspectives into the same room to spark bold, practical solutions. We balance ambition with support—valuing kindness as much as performance—so you can stretch into new responsibility while knowing others have your back. Here, your stability expertise does more than protect a shelf-life; it safeguards continuity of care and accelerates our ability to deliver meaningful therapies at scale.

Call to Action:
Ready to own stability decisions that keep life-changing medicines on the market and shape the next evolution of our commercial programme from Dublin—let’s make that impact together.

Date Posted

27-Jul-2026

Closing Date

09-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.