QMS Process Engineer

Roche • Mississauga, ON

5d • $111,000 - $206,100

About The Position

The QMS Process Engineer delivers operational excellence for specific Critical-to-Quality (CtQ) ecosystems by carrying out fit-for-purpose quality activities and driving the delivery and sustainability of a robust Quality Management System (QMS). The role partners across teams to design, implement, and optimize clear, data-driven execution workflows and integrates digital enablement, AI, and automation tools to streamline processes. It translates quality data into structured insights and trend analyses to identify actionable operational patterns. The position maintains alignment with global regulatory standards, including GxP, Pharmacovigilance, and IVD/Medical Device regulations, supports inspection readiness and regulatory intelligence analysis, and engages multidisciplinary stakeholders to guide compliant, sustainable process updates.

Requirements

• Bachelor’s degree in a scientific or quality-related field, or equivalent practical experience.
• Professional experience in a regulated GxP environment.
• Foundational understanding of process engineering frameworks such as Lean or Agile.
• Skills in data analytics and quality data storytelling, including using data to solve operational challenges and substantiate recommendations.
• Proactive self-starter able to navigate ambiguity, think critically, and take ownership to bridge operational gaps.
• Strong communication and relationship-building skills, with the ability to influence without formal authority and partner effectively across teams.

Responsibilities

• Deliver operational excellence for specific Critical-to-Quality ecosystems by executing fit-for-purpose quality activities.
• Drive the delivery and sustainability of a robust Quality Management System.
• Partner across teams to design, implement, and optimize clear, data-driven execution workflows.
• Integrate digital enablement, AI, and automation tools to streamline processes.
• Translate quality data into structured insights and perform trend analyses to identify actionable operational patterns.
• Maintain alignment with global regulatory standards, including GxP, Pharmacovigilance, and IVD/Medical Device regulations.
• Embed Critical-to-Quality principles into system design.
• Support inspection readiness and analyze regulatory intelligence to assess the impact of emerging regulations.
• Engage multidisciplinary stakeholders to guide compliant, sustainable process updates.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for benefits detailed at a linked location.

What This Job Offers

• Job Type: Full-time