QMS Process Engineer: Data-Driven Quality & Compliance

Genentech

South San Francisco (CA)

On-site

USD 111,000 - 206,000

Full time

3 days ago

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Benefits offered by this job

Discretionary annual bonus

Job summary

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.

Responsibilities

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.

Skills

GxP experience

Lean/Agile

Data analytics

Cross-functional

Problem solving

Education

Bachelor's degree in scientific/quality field

Job description

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

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