P2614 - Pharmaceutical Quality (pQM) Specialist

Together, we innovate, we impact, we grow !At Debiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we’re driven by science, but above all, by the people behind every treatment — the patients and their families. Through our unique “development only” model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster.   We are currently seeking a dedicated professional to join our Quality Management – R&D team  in Lausanne, Switzerland. In this role, you will be a key contributor to our Pharmaceutical Quality Unit (pQM), providing essential GMP support to development projects and external manufacturing partners, as a

Pharmaceutical Quality (pQM) SpecialistPermanent role | Lausanne, Switzerland     Your Mission:Your primary goal is to ensure robust oversight of quality documentation and vendor activities while strengthening our Pharmaceutical Quality System (PQS). You will help drive an agile, fit-for-purpose PQS that supports the high-quality development of investigational medicinal products for our patients.

Your Key Responsibilities ·       External Partnership Management: Contribute to the preparation, negotiation, and implementation of Quality Agreements with CDMOs.  ·       Project Representation: Act as the pQM representative for assigned development projects, offering GMP guidance throughout the product lifecycle.  ·       Quality Documentation: Manage the lifecycle of pharmaceutical quality documentation and oversee the archiving and verification of Batch Record Review files.  ·       System Operations: Support Quality Leads in managing deviations, CAPAs, change controls, and OOS/OOT events.  ·       Compliance & Inspection: Collaborate with internal teams and CDMOs to ensure inspection readiness and support quality risk management activities. ·       Continuous Improvement: Help draft SOPs, coordinate GMP training, and analyze quality KPIs to enable data-driven decision-making.