Quality Management System Process Engineer

Roche; Mississauga; On-site; GBP 56,000 - 73,000; Full time

Job summary

Roche in Mississauga is seeking a QMS Process Engineer to deliver operational excellence across CtQ ecosystems, turning raw data into actionable quality insights and embedding regulatory expectations into process design.

You will partner with cross-functional teams to design data-execution workflows, connect AI and automation to streamline workflows, and support inspection readiness while maintaining data accuracy and CtQ compliance.

Qualifications

• Bachelor's degree in scientific or quality discipline with 5+ years in a regulated environment.
• Experience in GxP (GCP, GVP, IVD/MD).
• Lean Six Sigma certification preferred.
• Strong data analytics and data storytelling abilities.
• Excellent communication and stakeholder-influence skills.

Responsibilities

• Design, implement, and optimize data-execution workflows.
• Connect AI and automation to streamline workflows and enhance system capability.
• Digest raw data into structured information and perform trend analyses.
• Maintain awareness of GxP regulations and embed CtQ in processes.
• Support inspection readiness and monitor process and data accuracy.
• Collaborate cross-functionally to guide QMS updates and compliance.

Skills

Data analytics

Quality data storytelling

GxP experience

Lean Six Sigma

Stakeholder influence

Education

Bachelor's degree in a scientific or quality-related discipline

Job description

At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. As a QMS Process Engineer, you will apply your expertise to deliver operational excellence across specific "Critical-to-Quality" (CtQ) ecosystems, executing fit-for-purpose quality activities and sustaining a robust Quality Management System (QMS). You will join a dynamic environment where your work directly bridges the gap between raw data and actionable quality insights. By leveraging digital tools, automation, and process engineering methodologies, you will streamline workflows, embed regulatory expectations into process design, and support inspection readiness. This role offers an exciting opportunity to partner cross-functionally, influence QMS evolution, and champion continuous improvement across our global operations. The Opportunity:

• Partner with the business to design, implement, and optimize data-execution workflows and processes.
• Connect AI and automation tools to streamline linear workflows and maximize system capabilities.
• Digest raw data into structured information and conduct trend analyses to identify patterns and systemic findings.
• Maintain up-to-date awareness of GxP regulations (especially GVP) and embed CtQ principles into process design.
• Support inspection preparation activities and monitor performance indicators to maintain process and data accuracy.
• Collaborate with cross-functional teams to guide compliance updates, influence QMS decisions, and offer guidance to peers.

Who You Are

Help yourself visualize success in this role by bringing your data-driven mindset, resilience, and collaborative spirit to a team that values innovation and clarity in complex environments. You enjoy solving operational challenges independently while building strong, win-win partnerships across an enterprise network.

• A Bachelor's degree or equivalent in a scientific or quality-related discipline (or equivalent practical experience) with at least 5 years of experience.
• Professional experience in a regulated GxP environment, with solid knowledge of end-to-end product development and operationalization (GCP, GVP, IVD/MD).
• Strong understanding of process improvement methodologies (e.g., Lean or Agile), with Lean Six Sigma certification preferred.
• High digital and data literacy, with proven experience in data analytics and using "quality data storytelling" to solve complex problems.
• Outstanding communication, presentation, and negotiation skills, with the ability to influence stakeholders with or without authority.
• Demonstrated capacity for critical thinking, independent problem-solving, and navigating ambiguity with an enterprise mindse.t

Preferred

• Digital and AI acumen in Safety environment

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.

The expected salary range for this position based on the primary location of Mississauga is 105,560.00 and 138,547.50 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.