The purpose of the role is managing pharmaceutical document management and logistics optimization, focusing on developing processes and GXP Documentation for Cell & Gene Therapy.
Major Accountabilities
• Develop and maintain documentation such as SOPs, WIs, and guidance documents, ensuring precision and clarity.
• Validate and innovate supply chain processes; create Service Orders, Request Forms, and Pro-ject charters.
• Manage logistics for products in Cell & Gene Therapy
• Oversee distribution and transport deviation, logistics, and supply chain management.
• Implement and manage work instructions for logistics for the CGT of pharmaceutical products.
• Conduct training on operations, mock shipments, packing instructions, and shipping solution assembly.
• Optimize end-to-end logistics operations, ensuring timely and accurate delivery of pharmaceu-tical products.
• Analyze data to extract actionable insights, supporting data-driven decision- making and con-tinuous process improvements.
• Facilitate cross-functional collaboration, ensuring cohesive documentation processes and en-hancing operational efficiency.
Education
• Degree in Science, Mechatronics, Biomedical Engineering or equivalent
Language: • Fluent in English • Professional working proficiency in French • Elementary proficiency in German • Additional European language expertise is an advantage
Work experience: At least 3 years of work experience in the field of expertise
Skills:
• Proven experience in pharmaceutical supply chain management and logistics.
• Demonstrated working experience in the area of gene therapies, immunotherapies, and/or cell therapies
• Familiarity with GXP documentation and regulatory compliance in the pharmaceutical industry.
• Knowledge of relevant industry standards & methods (ISO 14971, ISO 13485)
• Equipment know-how in Packaging & Laboratory
• Good knowledge of Software, Hardware & Firmware (ABB RobotStudio, Adobe Illustrator, Adobe Photoshop, MATLAB, Miro, Python, RoboExplorer, SOLIDWORKS
• Good organization, and planning skills
• Demonstrates problem-solving and idea- generation skills
• Very good communication, negotiation, and interpersonal skills. Ability to work in interdiscipli-nary teams
We offer great benefits: • Flat hierarchies and responsibility from the beginning
• People-oriented culture
• Diversity and inclusion-focused environment
• Global client projects in a multinational environment
• Flexible working hours and home office
• Involvement in global conferences
• Individual professional development, training, and coaching
• Unlimited full employment contract
• Excellent remuneration package consisting of a competitive salary plus a substantial bonus
If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your:
• CV, cover letter and supporting documents (i.e., diplomas, certificates, references) • Availability - earliest start date • Salary expectations • Location preference
Requested application types: via the portal Internet address:
http://www.kvalito.ch
Required attachments: Required attachments: CV, certificates Call up job offer details in the BA job search: 10000-1197983190-S
Email: magdalena.kurpierz@kvalito.ch and cc eures@afolmet.it