Quality & Compliance Lead

Genentech•Daly City, CA

About The Position

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. This role is based in Business Strategy & Operations (BSO) which serves as the strategic backbone and operational enabler for Product Development Data Sciences (PDD). The function ensures organizational excellence through robust quality frameworks, optimized resourcing, and aligned strategic execution. BSO brings together cross-functional capabilities across quality and compliance, workforce planning, and strategic operations to empower leaders and teams to deliver with focus, transparency, and accountability. By connecting enterprise priorities with operational realities, BSO drives consistency, clarity, and coordinated progress across PDD and the broader development organization. The Opportunity: The Quality & Compliance Lead within Business Strategy & Operations (BSO) plays a central role in ensuring the integrity, compliance, and quality of data-related processes, systems, and products across Roche’s PDD portfolio. Reporting to the Head of Quality & Compliance, this role oversees the development and implementation of operational standards and frameworks that align with evolving regulatory requirements and Roche-wide policies. The role leads a team of subject matter experts and is responsible for managing quality-related initiatives across functions, embedding a culture of compliance while enabling innovation at scale.

Requirements

You hold an advanced degree in life sciences, law, regulatory affairs, data governance, or a related discipline
You bring 12+ years of experience in regulatory, compliance, quality assurance, or data governance roles, with exposure to digital health or R&D environments
You have 3+ years of experience leading quality and compliance teams or projects within regulated healthcare or life sciences environments
You have strong working knowledge of global regulatory frameworks (e.g., HIPAA, GDPR, GxP, FDA, EMA) and their application to healthcare data and digital product development
You demonstrate experience implementing compliance frameworks in cross-functional or matrixed settings
You bring experience managing risk assessments, audits, or inspection readiness within data-driven or regulated environments
You have strong interpersonal skills and the ability to influence effectively across levels and functions
You have the capacity for independent thinking and the ability to make decisions based upon sound principles
You demonstrate excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond your technical domain
You demonstrate respect for cultural differences when interacting with colleagues in the global workplace
You have excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear, simple language

Nice To Haves

Familiarity with compliance practices for digital health products, SaMD, or AI/ML-based solutions
Experience leading or contributing to implementation of QMS for software-driven or data-intensive solutions
Exposure to regulated product development and product lifecycle quality practices
Prior involvement in cross-functional governance structures or policy-setting working groups
Knowledge of Roche enterprise compliance tools and policies is a plus

Responsibilities

You manage the execution of PDD quality and compliance initiatives across digital health, AI/ML, and data science domains, ensuring alignment with regulatory requirements and Roche global standards
You translate evolving global compliance requirements (e.g., GDPR, HIPAA, FDA, EMA) into actionable procedures and systems across PDD teams
You lead the design and continuous improvement of scalable frameworks for data lifecycle management, auditability, FAIR principles, and quality assurance
You ensure product and solution development teams adhere to applicable policies, including QMS for SaMD, data protection, and risk documentation
You coordinate compliance input into product lifecycles across exploratory, development, and deployment phases of digital and AI-enabled tools
You support cross-functional teams in preparing for internal audits, inspections, and risk assessments, and you manage resolution tracking
You represent the PDD function in quality and compliance working groups across Roche, aligning functional processes with enterprise expectations
You identify opportunities to streamline compliance processes while ensuring robustness, traceability, and adherence to best practices
You lead a team of quality, compliance, and regulatory operations professionals, providing clarity, direction, and performance management
You oversee prioritization, planning, and resource allocation across a portfolio of quality and compliance projects, ensuring timely and effective delivery
You coach and mentor direct reports and junior leaders to strengthen Roche’s internal capabilities in digital and data compliance
You build collaborative relationships across PDD, including with Data Science, Product, Legal, Regulatory, Diagnostics, and Clinical teams
You promote a culture of compliance, integrity, and continuous learning across the department
You contribute to departmental planning, budgeting, and talent development, ensuring alignment with mid-term strategic objectives
You partner with the Quality & Compliance Lead to represent the function in leadership discussions and enterprise initiatives