GxP Supplier Quality Manager
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
Let's build a healthier future together.
At Roche, we bring together our unique strengths in pharmaceuticals and diagnostics to tackle the toughest health challenges. Joining Roche means being part of a team that values integrity, courage, and passion, working together to transform the future of medicine and make a lasting impact on patients worldwide.
Roche is a global pioneer in pharmaceuticals and diagnostics, focused on advancing science to improve people’s lives. As one of the world’s largest biotech companies and a leader in in-vitro diagnostics, we are committed to driving personalized healthcare and delivering innovative solutions that address significant unmet medical needs. Joining Roche means being part of a team that values integrity, courage, and passion, working together to transform the future of medicine and make a lasting impact on patients worldwide.
The Opportunity
Support quality and compliance oversight for external GxP suppliers including CMOs, CRO/PET centers, CLOs and in-licensing partners to ensure compliance with cGMP and quality agreement requirements. You serve as the Quality Point of Contact for designated GxP suppliers and participate as a key member of cross-functional teams to assist in site selection, qualification and implementation, ongoing quality supply of commercial and investigational medicinal products, and decommissioning.
Oversee required quality activities during the lifecycle of a GxP supplier including but not limited to: process and method validations, Roche audits and Health Authority inspections, investigations, complaints, and regulatory submissions. You develop, negotiate, maintain and update Quality Agreements and Product Specific Requirements with GxP suppliers to ensure ongoing compliance with established agreements.
Collaborate with GxP suppliers to track and facilitate the closure of audit findings, CAPA implementation, deviation reporting, investigation closure, complaint management, and change implementation, ensuring Key Performance Indicators are monitored and reported.
Execute assigned activities to support Make Assess Release of commercial or investigational medicinal products, including reviewing and approving master process documentation, gathering data for investigation resolution, and monitoring GxP Supplier quality performance.
Who You Are
Education & Experience: B.S., M.Sc. or PhD in life sciences or equivalent.
5-7 years of Manufacturing and/or Quality experience in the pharmaceutical industry.
Technical Knowledge: Sound knowledge of cGMP, ISO standards, and international regulations. Ability to apply quality standards to routine GxP supplier activities.
Collaboration: Proven ability to work effectively within cross-functional teams and across cultures to meet shared goals.
Mindset: An agile professional who thrives in a collaborative environment, with a focus on executing tasks with precision and a continuous improvement mindset.
Accountability: Ability to take responsibility for assigned roles and tasks, ensuring individual effectiveness while contributing to the broader team.
Communication: Ability to communicate clearly and professionally in English, both in writing and verbally.
Travel: This position may require up to 10% domestic and/or international travel.
**Relocation benefits are not available for this posting**
The expected salary range for this position based on the primary location of Mississauga is 115,328.00 and 151,368.00 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.