QMS Process Engineer
- Mississauga, ON, Canada
The expected salary range for this position based on the primary location of South San Francisco, CA is $111,000 - $206,100. · Full-time
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Job details
- Pay
- The expected salary range for this position based on the primary location of South San Francisco, CA is $111,000 - $206,100.
- Job type
- Full-time
- Apply by
- Posting language
- English
- Posted
Original job description
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech / Roche!
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.
The Opportunity
As QMS Process Engineer you will use your expertise to deliver operational excellence of specific "Critical-to-Quality" (CtQ) ecosystems by executing fit-for-purpose quality activities and driving the delivery and sustainability of a robust Quality Management System (QMS).
- Partner across teams to design, implement, and optimize clear data-driven execution workflows.
- Integrate modern digital enablement, AI, and automation tools to streamline linear processes.
- Translate raw quality data into structured insights, performing trend analyses to identify actionable operational patterns.
- Maintain alignment with global regulatory standards (including GxP, Pharmacovigilance, and IVD/Medical Device regulations) to embed "Critical-to-Quality" principles into system design.
- Support inspection readiness and regulatory intelligence analysis to assess the impact of emerging regulations.
- Proactively engage with multi-disciplinary stakeholders to guide compliant, sustainable process updates.
- Education & Experience: Bachelor’s degree in a scientific or quality-related field (or equivalent practical experience), with professional experience in a regulated GxP environment.
- Process Methodology: Strong foundational understanding of process engineering frameworks (such as Lean or Agile).
- Data & Digital Literacy: Skilled in data analytics and quality data storytelling, with experience using data to solve operational challenges and substantiate recommendations.
- Problem Solving & Ownership: Proactive self-starter who navigates ambiguity with critical thinking and takes ownership to bridge operational gaps.
- Collaboration & Influence: Strong communicator and relationship-builder with the ability to influence without formal authority and partner effectively across teams.
Please kindly provide a cover letter alongside your CV.
The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of South San Francisco, CA is $111,000 - $206,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at link provided below.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
More about this job
Responsibilities
Deliver operational excellence for Critical-to-Quality ecosystems by executing quality activities and sustaining a robust Quality Management System. Design and optimize data-driven workflows, use digital tools and analytics to improve processes, and support regulatory alignment and inspection readiness.
Requirements
A bachelor’s degree in a scientific or quality-related field, or equivalent practical experience, and professional experience in a regulated GxP environment are required. Candidates should understand Lean or Agile process frameworks, use data analytics to address operational challenges, take ownership amid ambiguity, and collaborate effectively across teams.
Skills
- Quality Management Systems
- Process Engineering
- GxP Compliance
- Data Analytics
- Trend Analysis
- Lean Methodology
- Agile Methodology
- Digital Enablement
- Artificial Intelligence
- Automation
- Regulatory Intelligence
- Inspection Readiness
- Pharmacovigilance
- Medical Device Regulations
- Stakeholder Collaboration
- Critical Thinking
Visa sponsorship
Not detected in the job text
Categories
- Engineering
- Healthcare
- Manufacturing
- Data & Analytics
- Science & Research
Keywords
- Quality Management System
- Critical-To-Quality
- GxP
- Pharmacovigilance
- IVD Regulations
- Medical Device Regulations
- Process Engineering
- Lean
- Agile
- Data Analytics
- Quality Data Storytelling
- Trend Analysis
- Digital Enablement
- Artificial Intelligence
- Automation
- Regulatory Standards
- Regulatory Intelligence
- Inspection Readiness
- Operational Excellence
- Data-Driven Workflows
- Process Optimization
- Pharma Development
- Biotechnology Research