Quality & Compliance Lead

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.

• 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

Who you are:

• 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

Preferred Qualifications:

• 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

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $180,900.00 $335,900.00.  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.

Benefits

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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.

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