External Quality System 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
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
The External Quality Systems Manager supports the implementation, maintenance, and continuous improvement of compliant Quality Management Systems (QMS) across the end-to-end External Quality organization. Ensures alignment with Roche standards and global regulatory requirements while enabling effective oversight of external partners across development, clinical, and commercial phases. Partners with cross-functional stakeholders to monitor system performance, identify risks and improvement opportunities, and drive fit-for-purpose, patient-centric solutions that enhance quality, compliance, and operational efficiency.
Mission of External Quality:
Roche partners with external organizations to ensure patients have access to quality products while maintaining flexibility and cost-efficiency. Through cross-functional collaboration and a focus on quality and compliance, these partnerships enable reliable delivery of products to patients worldwide.
Main Purpose of the Position:
This role focuses on implementing, maintaining, and continuously improving compliant Quality Management Systems (QMS) across the end-to-end External Quality organization. It ensures alignment with Roche standards and global regulatory requirements while supporting effective oversight of external partners across development, clinical, and commercial phases, and driving fit-for-purpose, patient-centric processes that enhance quality, compliance, and operational efficiency.
The Opportunity:
Act as a Business Process Manager (BPM) for key Quality Systems across the end-to-end External Quality organization, ensuring processes are compliant, effective, and aligned with global regulatory requirements and Roche standards
Oversee system performance through metrics, trend analysis, and root cause investigations, while supporting audits and health authority inspections.
Working across development, clinical, and commercial phases, you will partner with internal and external stakeholders to align on quality expectations, provide subject matter expertise, and proactively manage quality and compliance risks.
Drive continuous improvement and innovation across Quality Systems. You will lead or contribute to system enhancements, process upgrades, and digital initiatives, applying Lean and structured problem-solving methodologies to improve efficiency and reduce complexity.
Acting as a change agent, you will help embed a culture of operational excellence, develop training and tools, and support capability building across the organization, all while managing competing priorities and contributing to broader organizational objectives.
Who You are:
You bring a degree in Life Sciences (e.g. Chemistry, Chemical Engineering, Engineering, Pharmacy, Biochemistry ) with at least 12 years of experience in the pharmaceutical, biopharmaceutical, or related industry, along with strong knowledge of cGMP and global quality system regulations.
Demonstrated experience influencing cross-functional stakeholders and global network partners without direct reporting authority with experience in supplier management.
Experience mentoring and coaching colleagues across diverse functions to foster capability building and technical expertise throughout the broader organization.
Ability to autonomously lead highly complex quality/compliance issues with implications extending beyond the immediate department, including the capacity to deputize for leadership as required.
Strong ability to anticipate complex quality or compliance risks and recommend innovative, proactive solutions before they impact product supply or regulatory standing
Proven ability to communicate complex ideas and influence stakeholders both within and outside the immediate business area to adopt new solutions and resolve critical issues
Expertise in identifying pain points and driving continuous improvement initiatives that deliver value not only to the immediate team but also to other organizations and the end-to-end patient supply process
Relocation benefits are not available for this job posting.
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.