Overview
In this role you will lead the design and implementation of compliant, secure, and high-quality data systems for Roche’s computational science platforms. You will partner with cross-functional teams to modernize the CSV framework and ensure GxP alignment, risk-based validation, and audit readiness. You will translate complex regulatory requirements into actionable guidance and embed security-by-design across architectures. This position offers impact by enabling innovative, data-centric science while safeguarding regulatory and security standards. You will shape validation and compliance practices that support scalable, cloud-native solutions across gRED and pRED.
Verantwortungsbereiche
- Define, implement, and advance CSV and validation frameworks with automation and continuous validation
- Ensure systems and workflows meet risk-based validation and GxP/regulatory standards
- Create and manage lifecycle documentation (validation plans, test protocols, traceability artifacts) for audit readiness
- Perform risk assessments for internal and vendor systems and implement robust controls
- Provide regulatory guidance on data integrity, audit trails, and system lifecycle controls
- Embed security-by-design into platforms, covering IAM, encryption, monitoring, and incident response
- Act as SME for Roche Information Security framework and promote best practices across the organization
Zentrale Anforderungen
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or equivalent experience
- 8+ years of experience in CSV, GxP compliance, security, and risk assessment in regulated environments
- Strong regulatory knowledge including GxP, data integrity, and system lifecycle management
- Experience implementing validation and compliance frameworks for laboratory, cloud-based, or distributed systems; support for regulatory inspections
- Experience developing SOPs, validation templates, and compliance tooling
- Expertise in validating computerized systems (GCP/GLP) and supporting regulatory inspections
- Experience with software development lifecycles (AGILE/SCRUM) and tools (Jira, ServiceNow)
- Ability to translate complex regulatory requirements into actionable technical guidance for cross-functional teams
- Strong communication and influencing skills
- Mentoring and leadership
- Cross-functional collaboration
- CSV validation and lifecycle management
- GxP compliance and regulatory frameworks (NIST, ISO 27001 knowledge)
- Security-by-design
Technical Project Manager, Security, Compliance & Valdiation in Basel Arbeitgeber: Roche
Roche ist ein hervorragender Arbeitgeber, der eine inklusive und respektvolle Arbeitskultur fördert, in der jeder Mitarbeiter geschätzt wird. Als Biostatistiker (m/w/d) in der Forschung und Entwicklung hast du die Möglichkeit, in einem interdisziplinären Team an innovativen Lösungen zu arbeiten und deine Fähigkeiten kontinuierlich weiterzuentwickeln. Zudem bietet Roche zahlreiche Möglichkeiten zur beruflichen Entfaltung und unterstützt aktiv die persönliche Entwicklung seiner Mitarbeiter.
