Life Science Consultant Cell Gene Therapy Supply Chain Process Manager

We are looking for enthusiasts

KVALITO is a strategic partner and global quality and compliance services and network for regulated industries with a prime focus on life sciences. Headquartered in Basel Switzerland we have subsidiaries in Germany Czech Republic Ireland Italy Spain and Malaysia. In our clients new organization Digital and Operational Excellence we aim to drive global development and execution of technical operations. By catalyzing the power of data and digital skills we aspire to realize performance promises and deliver value to patients. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile KVALITO works with reliable Technology Partners worldwide. For more information please visit us at

Life Science Consultant Cell & Gene Therapy Supply Chain Process Manager

Location: Germany

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 Project 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 endtoend logistics operations ensuring timely and accurate delivery of pharmaceutical products.
• Analyze data to extract actionable insights supporting datadriven decisionmaking and continuous process improvements.
• Facilitate crossfunctional collaboration ensuring cohesive documentation processes and enhancing operational efficiency.

Minimum Qualifications and Experience

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 knowhow 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 problemsolving and ideageneration skills
• Very good communication negotiation and interpersonal skills. Ability to work in interdisciplinary teams

We offer great benefits

• Flat hierarchies and responsibility from the beginning
• Peopleoriented culture
• Diversity and inclusionfocused 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

Contact

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: