Senior Expert Global Quality Control

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

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.

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 (Masters or Ph.D. preferred) in Microbiology Molecular Biology Biotechnology

• You possess at least10years 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 136936.00 and 179728.50 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.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1