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 areYou hold an advanced degree (Master’s or Ph.D. preferred) in Microbiology, Molecular Biology, Biotechnology
You possess at least10+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 expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.
We use artificial intelligence to screen, assess or select applicants for this role.
This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
