Posted 12 days ago
QMS Process Engineer
@ Genentech
Mississauga, Ontario
Overview
Genentech is hiring a QMS Process Engineer to deliver operational excellence across Critical-to-Quality ecosystems and sustain a robust Quality Management System. The role designs data-driven workflows, runs trend analyses on quality data, and keeps processes aligned with GxP, pharmacovigilance and IVD/medical device rules. The posting states full-time work with a salary range of $111,000 to $206,100 in South San Francisco, plus a possible discretionary bonus.
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 regulatory standards
- Support inspection readiness and regulatory intelligence
Requirements summary:
- Bachelor's degree in scientific or quality field, or equivalent experience
- Professional experience in a regulated GxP environment
- Foundational knowledge of Lean or Agile frameworks
- Skilled in data analytics and quality data storytelling
- Ability to influence across teams without formal authority
Tools & skills
Source and dates
Employer career site / ATS feed · phenom
- Employer posting date
- 2026-10-25
- First seen by our source
- 2026-10-21
- Source record updated
- 2026-10-28
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Seniority | Mid level |
| Department | Product management |
| Hours per week | 40 (estimated) |
| Work setting | Office |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
| Languages | English |
| Encouraged to apply | People with disabilities |
| Education | Bachelor’s degree (required) |
| Fields of study | Scientific field, Quality-related field |
| Perks mentioned | Performance bonus |
Summary and details written by AI from the posting; the employer’s posting is the authority.
Genentech
| Field | Value |
|---|---|
| Open jobs on Jobsy | 2 |
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.
YourApplication
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.
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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