Senior Expert Global Quality Control

Roche • Mississauga, ON

10d • CA$136,936 - CA$179,729 • Remote

About The Position

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.

Requirements

• Advanced degree (Master’s or Ph.D. preferred) in Microbiology, Molecular Biology, Biotechnology
• At least 10+ years of hands-on microbiological Quality Control experience within the pharmaceutical or biopharmaceutical industry.
• Proven track record of leading international, cross-functional projects, managing QA workflows, and driving change across complex matrix organizations.
• Expert technical mastery in classical microbiology, rapid microbiological methods (RMM), and modern molecular diagnostics.
• In-depth knowledge of global regulatory expectations and pharmacopeial standards, including EU/FDA GMP, GCLP, and ISO requirements.
• Skilled at synthesizing complex scientific concepts into compelling business cases and strategic roadmaps for executive decision-makers.
• Exceptional written and spoken English skills, enabling communication with clarity, authority, and influence across global teams and regulatory bodies.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior