GxP Supplier Quality Manager

Roche • Mississauga, ON

11d • Onsite

About The Position

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.

Requirements

• B.S., M.Sc. or PhD in life sciences or equivalent.
• 5–7 years of Manufacturing and/or Quality experience in the pharmaceutical industry.
• Sound knowledge of cGMP, ISO standards, and international regulations.
• Ability to apply quality standards to routine GxP supplier activities.
• Proven ability to work effectively within cross-functional teams and across cultures to meet shared goals.
• An agile professional who thrives in a collaborative environment, with a focus on executing tasks with precision and a continuous improvement mindset.
• Ability to take responsibility for assigned roles and tasks, ensuring individual effectiveness while contributing to the broader team.
• Ability to communicate clearly and professionally in English, both in writing and verbally.

Responsibilities

• 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.
• Serve as the Quality Point of Contact for designated GxP suppliers.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior