Katia Garcia Diz
Estelle Kotelon
HC-GM-DDBIA Analytical Op QC Lab BDC
Corsier-sur-Vevey | Route de Fenil Z.I.B.
As a Digital QC Expert in the Biotech Development Center, you will be a key player in shaping and implementing digital solutions to support Quality Control (QC) activities across clinical Phase I & II development. You will lead initiatives for laboratory digitalization, support LIMS activities and drive qualifications related to computerized systems (CSV). Furthermore, you will act as a digital project lead within QC, working in close collaboration with our Digital & Innovation team to optimize processes, enhance data integrity, and ensure compliance with regulatory requirements. Your expertise in digital technologies and scientific workflows will contribute to driving operational efficiencies and facilitating data-driven decision-making.
This role combines technical expertise, project leadership, and operational support, making you a central point of contact for QC digital topics in the Biotech Development Center.
Responsibilities:
Digital Project Leadership
* Lead QC digitalization projects in close collaboration with the Digital & Innovation team, ensuring alignment with QC operational needs and compliance requirements.
* Evaluate and implement new digital solutions tailored to Quality Control activities (e.g., Laboratory Execution System (LES), electronic documentation, data analytics, equipment integration).
* Drive continuous improvement of existing QC digital systems.
* Act as the digital ambassador for QC, fostering innovation and supporting the adoption of modern digital tools within the department.
GLIMS Masterdata & Routine Operations
* Configure GLIMS systems to meet laboratory requirements and industry standards.
* Manage and maintain QC master data in GLIMS ensuring proper configuration.
* Act as key user, providing first-line support, troubleshooting, training and access management for QC teams in routine.
* Ensure system performance, data integrity, and audit readiness through continuous monitoring and alignment with GMP/GxP standards.
* Stay updated on emerging LIMS technologies and industry best practices to drive continuous improvement and innovation.
CSV Computerized System Qualification
* Collaborate with CSV expert and support qualifications activities for QC related digital systems (e.g. Empower, SDMS, etc.).
* Prepare and execute validation documentation (User Requirements, risk assessments, protocols, reports) in alignment with GxP requirements.
* Coordinate with QC, QA, IT, to ensure compliant deployment of computerized systems.
Who you are:
* CFC / BTS / University degree in Life Science, Computer Science, Information Systems, or similar discipline.
* 4 to 9 years of professional experience, including at least 2 years in the administration and configuration of LIMS or similar systems.
* Hands-on experience with computerized system validation (CSV) and a strong understanding of regulatory requirements (GMP/GxP, data integrity).
* Understanding of Quality Control workflows and processes.
* Passionate about innovation and digital transformation, with a strong drive to explore new technologies and improve existing systems.
* Excellent problem-solving skills and ability to troubleshoot technical issues.
* Strong communication skills and ability to collaborate effectively with cross-functional international teams.
* Well-organized and able to manage multiple tasks and projects simultaneously, with a strong sense of responsibility.
* You are fluent in English (B2 or higher), German or French is a plus.
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