External Quality System Manager

Roche • Mississauga, ON

20h • CA$136,936 - CA$179,729

About The Position

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.

Requirements

• Degree in Life Sciences (e.g. Chemistry, Chemical Engineering, Engineering, Pharmacy, Biochemistry)
• At least 12 years of experience in the pharmaceutical, biopharmaceutical, or related industry
• Strong knowledge of cGMP and global quality system regulations.
• Demonstrated experience influencing cross-functional stakeholders and global network partners without direct reporting authority
• 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

Responsibilities

• 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, 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. 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, 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.

What This Job Offers

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