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 Roche!
As a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatory’s (PDR) Quality & Compliance capability, you will be accountable for creating and maintaining PDR’s Quality Management System (QMS) framework. This includes fostering innovation, identifying and implementing continuous improvement opportunities and developing risk-based quality strategies.
Act as a trusted partner to senior business stakeholders, leading or supporting cross-functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes.
Collaborate with global teams to mature and sustain PDR’s Quality & Compliance capabilities.
Monitor external trends and regulatory changes to ensure ongoing readiness.
Identify opportunities for continuous improvement and drive strategic change initiatives.
Lead internal/external audits, Health Authority inspections, and risk assessments.
Ensure compliance with global regulatory standards including Good Clinical Practice / Good Pharmacovigilance Practice (GCP/GVP) and Medical Device related requirements, where applicable.
Optimize processes to enable operational excellence and maintain our license to operate.
You have a Bachelor’s degree or equivalent in a scientific or quality-related field.
You have a minimum of 7 years of experience in Quality & Compliance, Regulatory Affairs or Drug and/or Device Development, with a strong understanding of regulated environments, industry frameworks, data and digital systems.
You’re a strategic thinker and problem solver who thrives in a fast-paced, collaborative environment, driven by purpose, excited by innovation, and confident in influencing change across a complex organization.
You are skilled at analyzing complex quality data and translating these insights into clear, actionable executive reporting and strategic messages.
You possess exceptional verbal and written communication skills with proven ability to communicate and collaborate effectively across global/local matrixed teams and senior leadership.
You possess a continuous improvement mindset and a proactive approach to solving challenges, with the ability to assess end-to-end processes, identify inconsistencies, and improve process effectiveness and efficiency.
You can influence best practice adoption.
Experience with audits or inspections is a plus, but not essential.
Advanced degree in a scientific or quality-related field.
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 $141,100 - $262,100. 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 the 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
About Genentech
We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.
Making a difference in the lives of millions starts when you make a change in yours. If you’d like to join our team, view our openings at gene.com/careers.
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