About this role
Position Summary
The Senior Specialist enables flawless operational execution across finished product (FP) introductions, market expansions, site transfers, technical changes, and discontinuations. The role ensures governed processes, documentation integrity, and timely change control to protect patient supply and support growth in Alexion’s global markets.
Acting as a process and coordination expert, the Senior Specialist manages cross-functional task orchestration, master data readiness, artwork and labeling workflows, and compliance activities. The role drives right-first-time outcomes through rigorous SOP adherence, GxP compliance, and continuous improvement, escalating decisions and trade-offs to the Associate Director and senior stakeholders.
Job Duties & Responsibilities
- Operational Execution: Coordinate tasks, timelines, and dependencies for FP changes; manage launch readiness criteria, master data (GTINs, serialization), artwork workflows, and distribution setup.
- Change Control: Initiate and steward Veeva QMS change controls; complete risk assessments, impact analyses, and CAPAs; maintain audit-ready records and meeting minutes.
- Site Transfers & Discontinuations: Support transfer plans, PPQ alignment, and release milestones; execute orderly market exits (pack deactivation, last-time buys, inventory run-down).
- Stakeholder Engagement: Prepare materials for cross-functional forums; present status and risks; follow through on actions and route complex decisions for escalation.
- Continuous Improvement & Visualization: Maintain dashboards/heatmaps; identify cycle-time and right-first-time improvements; run small CI activities and standardize outcomes.
- Compliance: Ensure GMP/GxP, labeling, and serialization compliance in day-to-day execution; participate in audits.
Essential Skills/Experience
- Bachelor’s degree in Supply Chain, Engineering, Quality, or related field
- 5–8 years in pharma/biotech operations, supply chain, quality, or regulatory support with GxP exposure
- Experience with Veeva QMS, artwork/labeling systems, ERP/PLM master data, and serialization
- Strong coordination, documentation discipline, and stakeholder communication
- Execution discipline and attention to detail
- Clear status/risk reporting; influence without authority
- SOP/process mapping and RACI familiarity
- Basic BI/dashboard skills; CI/Lean problem solving
- Practical understanding of GMP/GxP and labeling/serialization
Date Posted
22-Jan-2026Closing Date
28-Jan-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.Other facts
About AstraZeneca
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What you'll do
- The Senior Specialist coordinates operational execution for finished product changes, ensuring timely change control and compliance. They manage cross-functional tasks, documentation integrity, and drive continuous improvement initiatives.
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