QMS Process Engineer

Genentech; South San Francisco (CA); Sur place; USD 111 000 - 206 000; Plein temps

Avantages offerts par ce poste

Discretionary annual bonus

Résumé du poste

Genentech in South San Francisco seeks a QMS Process Engineer to drive operational excellence within complex CtQ ecosystems through a robust Quality Management System. You will partner across teams to design data-driven workflows and advance digital enablement, AI, and automation to streamline processes.

You will translate raw quality data into actionable insights, perform trend analyses, and ensure alignment with GxP and regulatory standards while supporting inspection readiness and regulatory

Qualifications

• Bachelor's degree in a scientific or quality-related field; regulated GxP experience.
• Foundational understanding of Lean or Agile process frameworks.
• Experience using data to solve operational challenges and tell quality stories.

Responsabilités

• Deliver operational excellence of CtQ ecosystems within QMS.
• Partner across teams to design and optimize data-driven workflows.
• Integrate digital enablement, AI, and automation to streamline processes.
• Translate raw quality data into structured insights and trend analyses.
• Maintain alignment with global regulatory standards (GxP, pharmacovigilance).
• Support inspection readiness and regulatory intelligence analyses.

Connaissances

GxP experience

Lean/Agile

Data analytics

Cross-functional

Problem solving

Formation

Bachelor's degree in scientific/quality field

Description du poste

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.

Benefits

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.