Product Quality Lead

vor 2 Wochen

Vevey, Schweiz LHH Vollzeit

Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm, you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.

For our Translational Medicine organization based at our Headquarters in Lausanne, we are looking for a

You oversee the end-to-end management of biological samples in clinical trials, from feasibility to long-term storage, and from preclinical studies for repository. This role ensures compliance with ethical, regulatory, and analytical standards while collaborating with cross-functional teams to optimize biosample workflows.

Your responsibilities will be but not limited to:

  • Design and implement biosample handling strategies for clinical trials, ensuring alignment with study protocols, regulatory requirements, and SOPs.
  • Oversee the selection, qualification, and management of Central Laboratories, ensuring compliance with ICH GCP / GLP / IVDR and country-specific regulations, working in close collaboration with Clinical Trial teams and Translational Medicine.
  • Ensure proper biosample collection, storage, logistics, and analysis while addressing deviations and implementing corrective actions.
  • Lead the development of biosample-related trial documents, including Biosample Management Plans, Central Laboratory Manuals, and Data Transfer Specifications.
  • Oversee Central Laboratory sample kits preparation and delivery to clinical sites, clinical sample shipments to specialty labs, ensuring timely delivery while maintaining chain-of-custody integrity.
  • Manage clinical biosample and preclinical specimens retention and destruction in compliance with patient consent, study protocols, and regulatory guidelines.
  • Support audits and inspections by preparing documentation, addressing findings, and ensuring biosample processes meet compliance standards.
  • Act as a subject matter expert, driving innovation, process improvements, and training initiatives in biosample management.

Requirements:

  • Degree in Life Sciences or Healthcare with 5+ years of experience in clinical biosample management (end-to-end) at a sponsor.
  • Strong expertise in sample logistics, central lab operations, and global regulatory frameworks.
  • Understanding of ethical and legal requirements for handling human and non-clinical biospecimens.
  • Demonstrated knowledge of ICH GCP / GLP / IVDR and country-specific accreditations / certifications for Central Laboratories.
  • Understanding of regulatory requirements for handling nonclinical biospecimens.
  • Proficiency in stakeholder collaboration, problem-solving, and regulatory compliance.
  • Excellent organizational, communication, and time management skills.
  • Excellent communication in English, French is an asset.
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