Quality & Compliance Specialist

Genentech•Boston, MA

2d•$82,000 - $133,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in health sciences, biomedical informatics, regulatory science, or a related discipline.
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.
Familiarity with digital health regulations (e.g., HIPAA, GDPR) and basic QMS principles.
Capacity for independent thinking and the ability to make decisions based upon sound principles.
Excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond your technical domain.
Demonstrate respect for cultural differences when interacting with colleagues in the global workplace.
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.

Nice To Haves

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.

Responsibilities

Support the design, implementation, and monitoring of data quality and compliance standards across Roche’s PDD portfolio.
Work closely with subject matter experts, functional teams, and cross-functional stakeholders.
Support quality and compliance activities in digital and data science-related projects, including documentation and procedural adherence.
Assist in preparing regulatory documentation and ensuring conformance with internal templates and guidelines.
Help track compliance deliverables, updates, and training status across project teams.
Coordinate logistics for audit support and readiness checks.
Conduct basic reviews of data handling procedures and documentation consistency.
Liaise with senior compliance staff to ensure alignment with Roche frameworks and expectations.
Help prepare meeting materials, templates, and guidance documents under the supervision of senior team members.
Adhere to functional standards, participating in peer reviews or mentoring relationships to uphold quality while building expertise in quality and compliance methodology and expectations.