Quality & Compliance Specialist at Genentech

Daly City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

24 Dec, 25

Salary

153000.0

Posted On

25 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Compliance, Regulatory Standards, Data Quality Management, Digital Health Regulations, Problem Solving, Critical Thinking, Communication Skills, Documentation, Audit Support, Team Collaboration, Training Coordination, Strategic Agility, Cultural Sensitivity, Independent Judgment, Quality Management Systems

Industry

Biotechnology Research

Description

The Position Quality & Compliance Specialist Department Summary 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 Specialist within the Business Strategy & Operations (BSO) function plays a critical role in supporting the design, implementation, and monitoring of data quality and compliance standards across Roche’s PDD portfolio. Working closely with subject matter experts, functional teams, and cross-functional stakeholders, these roles contribute to ensuring Roche’s digital and data-driven initiatives meet regulatory, legal, and enterprise policy requirements. Responsibilities and independence increase progressively by grade level. You exercise independent judgment to address moderately complex quality and compliance challenges, interpret and apply relevant guidance with minimal supervision, prioritize competing tasks effectively, and escalate nuanced issues requiring deeper contextual or domain-specific insight. You support quality and compliance activities in digital and data science-related projects, including documentation and procedural adherence. You assist in preparing regulatory documentation and ensuring conformance with internal templates and guidelines. You help track compliance deliverables, updates, and training status across project teams. You coordinate logistics for audit support and readiness checks. You conduct basic reviews of data handling procedures and documentation consistency. You liaise with senior compliance staff to ensure alignment with Roche frameworks and expectations. You help prepare meeting materials, templates, and guidance documents under the supervision of senior team members. You adhere to functional standards, participating in peer reviews or mentoring relationships to uphold quality while building expertise in quality and compliance methodology and expectations. Who You Are You hold a Bachelor’s degree in health sciences, biomedical informatics, regulatory science, or a related discipline. You bring 2–4 years of experience in a compliance, quality, or regulatory support role in pharma, health tech, or R&D; or you hold an advanced degree with 0–2 years of equivalent work experience. You have familiarity with digital health regulations (e.g., HIPAA, GDPR) and basic QMS principles. 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 language. Preferred Qualifications Experience working with digital health products or AI/ML-related workflows. Knowledge of Roche standards or exposure to internal compliance and privacy teams. Interest in regulatory innovation and data quality management in clinical settings. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of California is $93,500.00 and $153,000.00. 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 #PDDT #PDDSSF 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.

Responsibilities

The Quality & Compliance Specialist supports the design, implementation, and monitoring of data quality and compliance standards across Roche’s PDD portfolio. This role involves assisting in regulatory documentation preparation, tracking compliance deliverables, and coordinating audit support activities.