At Kedrion, we believe that innovation and care must go hand in hand. Our mission is to enhance lives through our dedicated work in the field of rare and ultra-rare diseases.
As a global leader with a passionate team of 5,200 employees, we collect and fractionate plasma to produce and distribute 38 vital medicines worldwide, establishing ourselves as the fifth largest player in the plasma-derived products sector.
Job Summary
The resource supports the end-to-end rollout of a Laboratory Information Management System (LIMS) within the pharmaceutical Quality Control (QC) and Quality Assurance (QA) environment. This is a junior role designed to build capability in program planning and control, contributing to delivery against agreed scope, schedule, cost, and quality requirements, and supporting cross-functional coordination across QC, QA, IT, CSV, vendors, and other stakeholders under the guidance of the Program/Project Manager.
What you'll do
• Support the Program/Project Manager in planning and executing a LIMS rollout program across one or more sites.
• Create, maintain, and update integrated project plans (work breakdown structure, milestones, dependencies) and contribute to program governance materials (status decks, RAID logs, minutes, actions).
• Monitor and report progress against schedule, cost, and resource plans; track activities, deliverables, and critical path items.
• Support cost tracking, forecasting, and overall project budget verification; highlight variances, risks, and required corrective actions.
• Support the coordination internal and external resources (QC, QA, IT, CSV, vendors) to ensure timely completion of tasks and resolution of issues.
• Maintain and update RAID (Risks, Assumptions, Issues, Dependencies) and change control items; ensure decisions and actions are documented and followed up.
• Support preparation and facilitation of project meetings, workshops, and steering/working group sessions; ensure clear communication and follow-through.
• Contribute to quality and compliance activities related to computerized systems implementation (e.g., documentation readiness, traceability, review workflows).
Qualifications and need-to-know
- Solid understanding of pharmaceutical Quality Control laboratory workflows (e.g., sample management, testing execution, data review/approval, OOS/OOT support interfaces) and related documentation practices.
- Understanding of LIMS concepts and core functionalities (e.g., sample lifecycle, test assignment, results entry, calculations, specifications/limits, instruments/interfaces, reporting, audit trails).
- Knowledge of quality approaches for computerized systems implementation in regulated environments, including documentation discipline, traceability, and quality-by-design principles for system configuration and deployment.
- Experience contributing to project planning and control activities: building project plans, tracking tasks and milestones, and managing dependencies.
- Ability to monitor and consolidate project data for schedule, costs, resources, and budget tracking, ensuring accuracy and timely escalation of deviations.
- Strong communication skills, with the ability to translate complex project information into clear updates for different audiences.
- Proven ability to coordinate cross-functional teams and drive action follow-up in a structured, collaborative way.
- Organized, detail-oriented, and proactive; able to manage multiple priorities under tight timelines.
- Comfortable working with stakeholders at different levels, including laboratory users, QA, IT, and external vendors.
- Degree in Life Sciences, Chemistry, Pharmacy, Engineering, Computer Science, or equivalent experience.
- 0–2 years of experience in project coordination/program support roles, preferably within pharma/biotech or regulated laboratory environments (internship/thesis/project work considered).
- Proficiency with common project tools (e.g., MS Project or equivalent planning tools; Excel; PowerPoint); ability to build structured trackers and dashboards.
- Fluent English (spoken and written) required; Italian is a plus.
Preferred (Nice to Have)
- Hands-on exposure to LIMS implementation projects (requirements, configuration, testing, data migration, deployment, hypercare).
- Familiarity with CSV/validation lifecycle concepts and deliverables in regulated environments.
- Experience working with laboratory instruments/interfaces and data integrity topics.
- Knowledge of change management and training coordination for laboratory end users.
This announcement is addressed to applicants of both sexes (L. 903/77 - D.Lgs n. 198/2006) and also to those belonging to Protected Categories (L.68/99).