Senior Expert Global Quality Control
$136,936–$179,728 year
On-siteMississauga, Ontario, Canada
Job Summary
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. 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. 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 to influence emerging industry standards.
Required Qualifications
- Master's or Ph.D. 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
- 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**
Desired Qualifications
- Advanced degree (Master's or Ph.D.) preferred
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