Senior Quality & Compliance Specialist at Genentech

Tuusula, Uusimaa, Finland -

Full Time

Start Date

Immediate

Expiry Date

24 Dec, 25

Salary

182900.0

Posted On

25 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Frameworks, Compliance Documentation, Risk Assessments, Audit Readiness, Data Lifecycle Management, Traceability, Privacy Practices, Training Materials, Collaboration, Regulatory Standards, Problem-Solving, Critical Thinking, Cultural Sensitivity, Communication Skills, Digital Solutions, QMS Systems

Industry

Biotechnology Research

Description

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 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 independently lead and contribute to the implementation of quality and compliance frameworks for digital and data-related solutions in PDD, ensuring proactive alignment with evolving internal and external standards You drive the development of internal compliance documentation, risk assessments, and audit readiness efforts You apply Roche and external regulatory standards (e.g., HIPAA, GDPR) to guide robust data lifecycle management, traceability, and privacy practices, while identifying opportunities to strengthen compliance processes You provide compliance input into project workflows and solution reviews, collaborating with senior experts and cross-functional teams to drive adherence to best practices and mitigate compliance risks You design, develop, and deliver high-quality training materials, templates, and guidance to enable stakeholders to embed data quality and governance processes within their workflows You collaborate cross-functionally with legal, regulatory, and privacy teams to align on compliance deliverables and promote a unified approach to compliance You lead efforts to track, analyze, and report compliance metrics, maintaining up-to-date quality records across initiatives Who you are: You hold a Bachelor’s degree in life sciences, regulatory affairs, data governance, or a related field You bring a minimum of 5 years of experience in quality or compliance roles within healthcare, biopharma, or digital health contexts; or you hold an advanced degree with 3 years of equivalent work experience You have knowledge of relevant regulations and standards (e.g., GDPR, HIPAA, GxP) and their application to data-driven or digital projects You bring experience in audit support, SOP maintenance, or compliance documentation 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: Exposure to QMS systems and regulatory expectations for digital solutions Familiarity with Roche compliance tooling or enterprise standards Experience working in matrixed or global project settings #PDDT #PDDBoston Relocation benefits are available for this posting The expected salary range for this position based on the primary location of Boston is $98,500 - $182,900.00. 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 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 leads the implementation of quality and compliance frameworks for digital and data-related solutions, ensuring alignment with evolving standards. They also develop compliance documentation and collaborate with cross-functional teams to mitigate compliance risks.