GxP Supplier Quality Manager

Roche•Mississauga, ON

1d•Remote

About 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.

Requirements

Bachelor’s degree in Life Sciences or an equivalent field, backed by significant experience in the pharmaceutical or biotech industry.
Robust Quality Control expertise within the Pharma s, ensuring high standards of analytical and laboratory compliance.
Specialized experience with large molecules and biologics, showing a deep understanding of their unique characterization and stability requirements.
Skilled at managing complex manufacturing processes, with the ability to navigate the technical nuances of biological production cycles.
Highly knowledgeable in cGMP, ISO standards, and international regulations governing the manufacturing and distribution of medicinal products.
Ability to organize and prioritize effectively when faced with challenging, high-visibility situations.
Exceptional communication skills, with a proven ability to influence without authority and the transparency to raise concerns timely while remaining receptive to guidance.

Responsibilities

Serve as the primary Quality Point of Contact (PoC) for designated GxP suppliers, including CDMOs, CROs, and direct material providers.
Apply deep Quality Control expertise within Pharma s to oversee analytical testing, method validation, and lab compliance at external sites.
Manage the quality oversight of complex manufacturing processes, specifically focusing on the intricate requirements of large molecules and biologics.
Oversee critical "Make Assess Release" (MAR) activities, including batch documentation review, investigation resolution, and the release of biological products.
Lead the development, negotiation, and maintenance of Quality Agreements to ensure strict adherence to Roche and global regulatory standards.
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 and mitigate compliance risks associated with technical transfers and biologics manufacturing.