Quality Management System Process Engineer

Roche; Welwyn; On-site; GBP 56,000 - 74,000; Full time

Benefits offered by this job

Relocation benefits not available

Job summary

Roche seeks a QMS Process Engineer to deliver operational excellence across CtQ ecosystems, bridging data and quality insights. You will design data-execution workflows, embed GxP standards, and collaborate across functions to prepare for inspections while continuously improving processes with digital tools and AI capabilities.

You will bring 5+ years in regulated environments, strong communication, and a data-driven mindset to drive CtQ improvements in a global setting.

Qualifications

• Bachelor’s degree or equivalent in a scientific or quality-related discipline with 5+ years in a regulated GxP environment.
• Experience in end-to-end product development and operationalization (GCP, GVP, IVD/MD).
• Lean Six Sigma certification preferred; strong data literacy and storytelling.
• Excellent communication, presentation, and stakeholder influence skills.

Responsibilities

• Design, implement, and optimize data-execution workflows and processes.
• Connect AI and automation tools to streamline workflows and enhance system capabilities.
• Translate raw data into actionable quality insights and trend analyses.
• Maintain awareness of GxP regulations and embed CtQ principles in process design.
• Support inspection readiness and monitor performance indicators for data accuracy.
• Collaborate with cross-functional teams to guide QMS updates and provide guidance.

Skills

GxP knowledge

Data analytics

Process improvement

Lean Six Sigma

Quality data storytelling

Regulatory communication

Education

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

Tools

QMS software

AI tooling

Job description

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

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.

To be successful in this role, you bring:

• 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

Relocation Benefits are not available for this job posting.

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.

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.