Senior Expert Global Quality Control

At Roche, we are passionate about transforming patients’ lives. As a global healthcare leader operating in over 100 countries, we combine the strengths of our Pharmaceuticals and Diagnostics divisions to drive the future of personalized healthcare. We thrive on innovation, scientific excellence, and a shared commitment to delivering sustainable, high-quality medical solutions. As part of our ambitious 10-year Pharma vision, we are dedicated to delivering more benefits to patients by integrating innovative technology and systems into our lifecycle management processes. By joining Roche, you will be part of a dynamic, diverse, and inspiring environment where your work has a direct, meaningful impact on patients worldwide. Imagine shaping the future of microbiological quality control within a global network. As a Senior Expert Global QC, you are the driving force behind the evaluation and implementation of innovative rapid methods, taking the safety of our medicines to the next level. You combine deep technical expertise with strategic project management to ensure that groundbreaking technologies become the global standard. The Opportunity You will become part of a unit within Network QC that sets global standards. Here, you will work in a high-caliber environment of specialists who cooperate closely with internal and external partners. Your team is characterized by scientific curiosity and a drive to actively shape the modernization of microbial control concepts. Establish global Network QC standards, local alignment frameworks, and foundational technical documentation to elevate quality across manufacturing sites. Author and review technical dossiers, validation master plans, and scientific justifications to support health authority filings worldwide. Formulate forward-looking QC concepts, strategic business cases, and risk-based decision frameworks for executive management. Provide specialized scientific consultation and global troubleshooting for complex network investigations, deviations, and out-of-specification (OOS) events. Represent Roche Pharma Network QC in prominent international working groups and regulatory forums (such as PDA and ECA) to influence emerging industry standards. Drive the global evaluation, development, and validation of alternative and rapid microbiological methods (RMM) across the entire Roche Pharma Quality Control network. Direct cross-site harmonization and technology projects to transition legacy assays into modern, automated, or molecular testing platforms. Who you are You hold an advanced degree (Master’s or Ph.D. preferred) in Microbiology, Molecular Biology, Biotechnology You possess at least 10+years of hands-on microbiological Quality Control experience within the pharmaceutical or biopharmaceutical industry. You have a proven track record of leading international, cross-functional projects, managing QA workflows, and driving change across complex matrix organizations. You demonstrate expert technical mastery in classical microbiology, rapid microbiological methods (RMM), and modern molecular diagnostics. You bring in-depth knowledge of global regulatory expectations and pharmacopeial standards, including EU/FDA GMP, GCLP, and ISO requirements. You are skilled at synthesizing complex scientific concepts into compelling business cases and strategic roadmaps for executive decision-makers. You possess exceptional written and spoken English skills, enabling you to communicate with clarity, authority, and influence across global teams and regulatory bodies. **Relocation not available for this position**

The role involves establishing global Network QC standards and driving the implementation of innovative rapid microbiological methods across manufacturing sites. The expert will author technical dossiers for health authority filings and provide scientific consultation for complex network investigations.

Candidates must hold an advanced degree in Microbiology or a related field with over 10 years of pharmaceutical QC experience. Proficiency in global regulatory standards (EU/FDA GMP) and a proven track record of leading international cross-functional projects are required.

• Gestion de projetSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Microbiology
• Rapid Microbiological Methods (RMM)
• Quality Control
• Project Management
• Regulatory Compliance
• Molecular Diagnostics
• Validation Master Plans
• GMP
• GCLP
• ISO Requirements
• Technical Writing
• Strategic Planning
• Cross-functional Leadership
• Risk-based Decision Frameworks
• OOS Investigations

• Science & Research
• Healthcare
• Manufacturing
• Management & Leadership

Formation minimale

Maîtrise

Expérience minimale

10+ ans

Postuler avant le

22 août 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Mid-Senior level