Bachelor’s degree in a scientific or quality-related field or equivalent experience
Professional experience in a regulated GxP environment
Strong understanding of process engineering frameworks like Lean or Agile
Skilled in data analytics and quality data storytelling
Proactive self-starter with critical thinking skills
Strong communicator and relationship-builder
Responsibilities
Partner across teams to design and optimize data-driven workflows
Integrate AI and automation tools to streamline processes
Translate raw quality data into actionable insights
Maintain alignment with global regulatory standards
Support inspection readiness and regulatory analysis
Engage with stakeholders to guide compliant process updates
Benefits
Discretionary annual bonus based on performance
Comprehensive benefits package available
Opportunity for professional development
Collaborative work environment
Exposure to cutting-edge technologies and methodologies
Full Job Description
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.
About Roche
Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the largest pharmaceutical company in the world, and the leading provider of cancer treatments globally. The company also produces a range of diagnostic tests for medical professionals and patients. Roche was one of the first companies to bring targeted treatments to patients. In 2019, Roche had over 100,000 employees worldwide, and generated revenue of CHF 61.5 billion.
