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QMS Process Engineer

@ Genentech

Mississauga, Ontario

Full-time
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SIGNALS

Overview

Genentech is hiring a full-time QMS Process Engineer in South San Francisco, CA, to deliver operational excellence across Critical-to-Quality ecosystems and drive a robust Quality Management System. The role involves process design, data-driven trend analysis, regulatory alignment (GxP, Pharmacovigilance, IVD/Medical Device) and inspection readiness. The posted salary range is $111,000 - $206,100, plus a discretionary annual bonus that may be available.

Responsibilities:

  • Design and optimize data-driven execution workflows
  • Integrate digital tools, AI and automation into processes
  • Perform trend analyses on quality data
  • Maintain alignment with GxP and global regulations
  • Support inspection readiness and regulatory intelligence

Requirements summary:

  • Bachelor's in scientific or quality field, or equivalent experience
  • Professional experience in a regulated GxP environment
  • Foundational knowledge of Lean or Agile
  • Skilled in data analytics and quality data storytelling
  • Strong communication and cross-team influence

Tools & skills

Source and dates

Source type not verified · apify-linkedin

Employer posting date
Not provided
First seen by our source
2026-11-15
Source record updated
2026-11-15

These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.

Job details

DepartmentQuality assurance
Hours per week40 (estimated)
Work settingOffice
PositionMostly sitting
Physical demandsphysical low · computer high
LanguagesEnglish
Encouraged to applyPeople with disabilities
EducationBachelor’s degree (required)
Fields of studyScientific field, Quality-related field
Perks mentionedPerformance bonus

Summary and details written by AI from the posting; the employer’s posting is the authority.

Genentech

FieldValue
Open jobs on Jobsy2
Job description
The Position

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.

Who You Are

  • 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.

Your Application

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.

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