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 believe every patient deserves a better option. As a global leader in healthcare and a pioneer in pharmaceuticals and diagnostics, our mission is to transform the lives of millions by focusing on innovative science. We are a community of 100,000 people across 100 countries, pushing the boundaries of medical research to deliver personalized healthcare. By joining Roche, you become part of a culture that values courage, integrity, and passion, working together to solve some of the world’s most complex health challenges. The Opportunity As a Quality Manager for External Quality, you will play a pivotal role in ensuring the safety and efficacy of our products by providing rigorous oversight of our global GxP supplier network. Your contributions will directly impact our ability to deliver life-saving treatments to patients worldwide.

• Serve as the primary Quality Point of Contact (PoC) for designated GxP suppliers, including CDMOs, CROs, and direct material providers
• Manage the full lifecycle of supplier quality activities, from initial source and selection through implementation, management, and decommissioning
• Lead the development, negotiation, and maintenance of comprehensive Quality Agreements to ensure strict adherence to Roche and regulatory standards
• Oversee critical "Make Assess Release" (MAR) activities, including batch documentation review, investigation resolution, and the release or rejection of products
• Collaborate with cross-functional teams to provide quality expertise for in-licensing opportunities and M&A due diligence events
• Drive the resolution of complex quality issues and manufacturing deviations by fostering effective partnerships with external site leadership
• Utilize advanced quality risk management tools to identify, mitigate, and communicate potential compliance risks to Senior Management

Who You Are We are seeking a detail-oriented quality professional who thrives in a collaborative, fast-paced environment and possesses a deep commitment to regulatory excellence.

• You possess a Bachelor’s degree in Life Sciences or an equivalent field, backed by significant experience in the pharmaceutical or biotech industry
• You are highly knowledgeable in cGMP, ISO standards, and international regulations governing the manufacturing and distribution of medicinal products
• You demonstrate a proven track record of managing GxP suppliers such as CMOs and CLOs, ensuring they meet rigorous quality and timeliness benchmarks
• You are skilled at interpreting complex quality standards and applying them effectively to diverse supplier operations and direct material changes
• You possess exceptional communication skills, allowing you to negotiate Quality Agreements and influence internal and external stakeholders professionally
• You are proficient in utilizing digital tools and platforms, including MS Office or Google Suite, to manage data-driven quality metrics and project timelines
• You are capable of traveling up to 10% domestically and internationally to conduct site visits and support technical transfers or health authority inspections
• Relocation benefits 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.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.