Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

The Enterprise Systems Digital Assurance

Specialist supports Corporate QA IT in maintaining compliance and inspection readiness for Corporate IT systems and services used in a regulated environment. The role focuses mainly on technical assurance and qualification/validation support for platforms and operating models (cloud/Kubernetes, external data center services, integrations/data flows), and on emerging topics such as AI-enabled corporate solutions. The position also supports QA IT with ongoing quality activities across the lifecycle of corporate systems: review and control of documentation and supporting evidence (both validation-related and IT governance documentation), and support to change and release governance for high-impact changes.

The role works with IT teams, business stakeholders and external vendors to understand technical changes, confirm what controls and documentation are needed, and help ensure that the information is complete, consistent and ready for QA review and decisions. In addition, the role provides support for audit readiness activities (preparing and organising evidence, and supporting audit responses when required)



and supports problem/incident follow-up when there is regulated impact (reviewing the quality and completeness of records and ensuring appropriate linkage to changes and documentation when needed). The role may also support training activities related to IT QA procedures and controlled documentation, when required.

Reports to the QA IT Director (Corporate QA).Key AccountabilitiesProvide technical assurance support for corporate platforms (cloud/Kubernetes, external data center services, integrations), including qualification/validation support for QA review. Review validation and IT governance documentation to ensure completeness and audit readiness, progressively taking ownership of defined review activities under QA IT direction. Support regulated incident/problem follow-up and training activities related to IT QA procedures and controlled documentation, as needed.

Networking/Key relationshipsCorporate IT teams (Cloud/Infrastructure, Architecture, Development, Integrations, Security, Data & Analytics): technical inputs, evidence collection, readiness and follow-up actions. External vendors / service providers (cloud, data center, SaaS and integration partners): documentation/evidence inputs, release/change communication, responsibilities and follow-up.



Technical IT background (degree in IT/Engineering or equivalent hands-on experience). 2–4 years of practical IT experience in platforms/operations, infrastructure/cloud, enterprise applications, integrations, or DevOps.

Working understanding of cloud concepts and Kubernetes/containerised platforms (what they are, how they operate, and how changes/releases are managed). Understanding of how IT services are operated and changed (deployments, configuration changes, releases, incident/problem follow-up). Interest in working in a Quality Assurance environment and willingness to learn validation/assurance practices (training will be provided).

Experience with integrations/data flows and/or external data center services.

Technical

CompetencesUnderstanding of Enterprise system architectures, Cloud and SaaS delivery models, Data integrity and audit trail requirements. DevOps / Agile delivery models, Basic AI/ML concepts applied to business processes, Cybersecurity principles aligned with ISO 27001Regulatory & Quality KnowledgeStrong knowledge of GxP requirements and validation practices. Familiarity with ISO 13485 (QMS context, not product validation), EU MDR (as it impacts quality systems), GAMP 5 and CSA guidance Experience supporting inspections and audits. enterprise system validation Pragmatic, risk-based decision making Strong stakeholder alignment across business and IT Capability to operate in complex, matrix organizations Focus on scalability and efficiency, not just compliancTravel requirements:

📌 Digital Specialist- IT (Barcelona)
🏢 Werfen
📍 Barcelona