External Quality System Manager

Roche•Mississauga, ON

1d•Onsite

About The Position

At Roche, we foster a culture where individuality is embraced, and personal expression, open dialogue, and genuine connections are encouraged. We value, accept, and respect everyone for who they are, enabling personal and professional growth. Our mission is to prevent, stop, and cure diseases and ensure universal access to healthcare for present and future generations. Join Roche, where every voice matters. A healthier future is our driving force for innovation. We continuously advance science to ensure everyone has access to the healthcare they need, today and for generations to come. Our goal is to create a world where we all have more time with the people we love. This is what defines us at Roche. The External Quality Systems Manager plays a crucial role in implementing, maintaining, and continuously improving compliant Quality Management Systems (QMS) within the end-to-end External Quality organization. This role ensures adherence to Roche standards and global regulatory requirements, facilitating effective oversight of external partners throughout development, clinical, and commercial phases. By collaborating with cross-functional stakeholders, the manager monitors system performance, identifies risks and opportunities for improvement, and drives the development of fit-for-purpose, patient-centric solutions that enhance quality, compliance, and operational efficiency. Our External Quality mission is to partner with external organizations to ensure patients receive quality products while maintaining flexibility and cost-efficiency. Through cross-functional collaboration and a focus on quality and compliance, these partnerships enable the reliable delivery of products to patients worldwide. The main purpose of this position is to implement, maintain, and continuously improve compliant Quality Management Systems (QMS) across the end-to-end External Quality organization, ensuring alignment with Roche standards and global regulatory requirements, while supporting effective oversight of external partners and driving 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 five years of experience in the pharmaceutical, biopharmaceutical, or related industry.
Strong knowledge of cGMP and global quality system regulations.
Skilled at working in a matrix environment.
Ability to influence stakeholders.
Ability to communicate complex topics clearly.
Demonstrate strong problem-solving and decision-making abilities.
Possess a risk-based, patient-centric mindset.
Comfortable navigating complexity and ambiguity.
Take ownership and act with integrity.
Apply continuous improvement and operational excellence tools (e.g., Lean) to drive outcomes.
Proficiency in standard business tools.
Commitment to ongoing learning.

Nice To Haves

Experience in supplier management or supply chain.

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.
Partner with internal and external stakeholders across development, clinical, and commercial phases to align on quality expectations, provide subject matter expertise, and proactively manage quality and compliance risks.
Drive continuous improvement and innovation across Quality Systems, leading or contributing to system enhancements, process upgrades, and digital initiatives.
Apply Lean and structured problem-solving methodologies to improve efficiency and reduce complexity.
Act as a change agent to embed a culture of operational excellence, develop training and tools, and support capability building across the organization.
Manage competing priorities and contribute to broader organizational objectives.