Technical Product Owner/Manager

Roche Holding AG; Basel; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Roche Holding AG sucht einen erfahrenen Security, Compliance and Validation Technical Project Manager, um CSV- und GxP-Compliance-Standards in einer komplexen, regulierten Umgebung zu sichern. Sie arbeiten eng mit Quality, IT-Sicherheit und Rechtsabteilung zusammen, um robuste Validierungsprozesse zu etablieren.

Sie entwickeln und implementieren Sicherheits- und Compliance-Kontrollen, unterstützen Audits und regulatorische Inspektionen und treiben kontinuierliche Verbesserungen in Validation,

Qualifikationen

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or equivalent.
• 8+ years of CSV, GxP compliance, security, and risk assessment experience.
• Strong regulatory knowledge: GxP, data integrity, lifecycle management.
• Experience validating computerized systems and supporting inspections.
• Experience developing SOPs and validation templates.
• Experience with SDLC methodologies (AGILE/SCRUM).

Aufgaben

• Partner with Quality to modernize the Computerized System Validation (CSV) framework, including automation, continuous validation, and quality-by-design.
• Ensure that systems and workflows adhere to risk-based validation and applicable GCP/GLP regulations & standards.
• Create and manage lifecycle documentation, including validation plans, test protocols, and traceability artifacts, ensuring audit readiness.
• Perform comprehensive risk assessments for internal systems and vendor solutions, ensuring robust controls.
• Provide expert guidance on regulatory expectations, including data integrity, audit trails, and system lifecycle controls.
• Embed security-by-design into platform and product architectures (IAM, encryption, monitoring).
• Act as SME for Roche Information Security framework, promoting best practices and compliance awareness.

Kenntnisse

CSV & GxP compliance

Security risk assessment

Regulatory requirements (GxP)

Validation frameworks

SOPs & validation tooling

SDLC methodologies (Agile/Scrum)

Data integrity

Ausbildung

Bachelor’s degree (CS/Engineering/Life Sciences)

Tools

Jira

ServiceNow

Jobbeschreibung

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La 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!

Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche’s Research and Early Development organisations at Genentech (gRED) and Pharma (pRED) have demonstrated how these technologies accelerate R&D, leveraging data and novel computational models to drive impact. Seamless data sharing and access to models across gRED and pRED are essential to maximising these opportunities. The new computational sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness this transformative power of data and Artificial Intelligence (AI) to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide. Within the CoE organisation, the Data and Digital Catalyst (DDC) organisation drives the modernization of our computational and data ecosystems and integration of digital technologies across Research and Early Development to enable our stakeholders, power data-centric science and accelerate discovery.

The Security, Compliance and Validation Technical Project Manager is responsible for defining, implementing, and advancing frameworks that ensure scientific computing platforms and data systems meet regulatory, security, and quality standards. This role operates within the Security, Compliance and Validation (SCV) function and partners closely with Platform Engineering, Platform Enablement, and scientific teams to enable compliant, secure, and high-quality digital solutions. Beyond Scientific Computing, this role will partner closely with Roche Global Information Security, Product Development / pharma Research & Early Development Quality Assurance as well as Legal Officers and the Roche Computer System Validation group to ensure that our work is compliant with Roche Security system standards while meeting regulatory requirements.

This position combines deep expertise with regulatory and quality domain knowledge, ensuring that modern, cloud-native and data-intensive platforms can operate effectively within GxP and other regulated environments. The role emphasizes a risk-based, pragmatic approach to compliance and validation, enabling innovation while maintaining audit readiness and adherence to regulatory expectations.

The Security, Compliance and Validation Technical Project Manager is expected to act as a subject matter expert, influencing strategy, mentoring others, and driving continuous improvement in validation, security, and compliance practices across the organization.

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.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.