Technical Project Manager, Security, Compliance & Valdiation

Roche; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Roche seeks a senior CSV and regulatory specialist in Basel to partner with Quality and informatics teams to modernize the CSV framework, automate validation activities, and ensure alignment with GxP and data integrity requirements.

You will lead risk assessments, develop validation templates, support regulatory inspections, and promote secure by-design architectures across laboratory and cloud-based platforms at Roche.

Qualifikationen

• 8+ years of CSV, GxP compliance, security and risk assessment in regulated environments.
• 2nd item for balance

Aufgaben

• Partner with Quality to drive CSV framework modernization and automation.
• Ensure systems and workflows meet risk-based validation and GCP/GLP standards.
• Create and manage validation plans, test protocols, and traceability artifacts.
• Perform risk assessments for internal systems and vendor solutions.
• Provide guidance on regulatory expectations including data integrity and audit trails.
• Embed security-by-design into platform and product architectures, including IAM and monitoring.
• Act as SME for Roche Information Security framework across Computational Sciences.

Kenntnisse

CSV and GxP compliance

Security risk assessment

Regulatory strategy guidance

Agile/SCRUM methodologies

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Computer Science, Engineering, or Life Sciences

Tools

Jira

ServiceNow

Jobbeschreibung

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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!

The Opportunity

• Partner with Quality to co-drive the modernization and optimization of the Computerized System Validation (CSV) framework, including automation, continuous validation, and quality-by-design; drive the efficient application of the CSV processes to products & platforms
• Ensure that systems, and workflows adhere to risk-based validation and applicable GCP or GLP regulations & organizational standards
• Create & manage lifecycle documentation, including validation plans, test protocols, and traceability artifacts, ensuring complete audit readiness
• Perform comprehensive risk assessments for internal systems and vendor solutions, ensuring robust controls are implemented and documented
• Provide expert guidance on regulatory expectations, including data integrity, audit trails, and system lifecycle controls
• Embed security-by-design into platform and product architectures, including IAM, encryption, and monitoring (i.e. support incident response, vulnerability management, and continuous security improvements).
• Act as a subject matter expert for the Roche Information Security framework, promoting best practices and compliance awareness across the Computational Sciences organization

Who You Are

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or equivalent experience
• 8+ years of experience in CSV, GxP compliance, security, and risk assessment within regulated environments
• Strong understanding of regulatory requirements, including GxP guidelines, data integrity, and system lifecycle management, and knowledge of security frameworks and standards (e.g., NIST, ISO 27001)
• Proven experience implementing validation and compliance frameworks for laboratory, cloud-based, or distributed systems, and supporting regulatory inspections or audits
• Experience developing SOPs, validation templates, and compliance tooling
• Expertise in leading the validation of computerized systems (preferably GCP/GLP) and supporting regulatory inspections
• Significant experience with software development lifecycle methodologies (AGILE/SCRUM) and lifecycle management tools (e.g., Jira, ServiceNow)
• Demonstrated ability to translate complex regulatory requirements into actionable technical guidance for cross-functional scientific and engineering teams

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.