QMS Process Engineer

F. Hoffmann-La Roche AG; South San Francisco (CA); On-site; USD 111,000 - 206,000; Full time

Job summary

Genentech in South San Francisco, CA is seeking a QMS Process Engineer to elevate operational excellence of Critical-to-Quality ecosystems by executing fit-for-purpose quality activities and sustaining a robust Quality Management System (QMS).

You will translate quality data into structured insights, drive data-driven workflows, and partner across teams to implement digital enablement, AI, and automation while maintaining compliance with GxP and regulatory standards.

Qualifications

• Bachelor’s degree in a scientific or quality-related field with relevant experience in a regulated GxP environment.
• Strong foundational understanding of process engineering frameworks such as Lean or Agile.
• Experience using data to solve operational challenges and substantiate recommendations.

Responsibilities

• Deliver operational excellence of CtQ ecosystems and maintain a robust QMS.
• Translate quality data into structured insights and drive data-driven workflows.
• Partner across teams to design and implement digital enablement, AI, and automation tools.

Skills

Quality systems

Data analytics

Lean/Agile

Collaboration

Education

Bachelor’s degree in a scientific or quality-related field

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.

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.

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.

Relocation benefits are not available for this job posting.

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.

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life‑threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.

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.