5 months ago

Lead Expert, Digital Quality Management

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Last checked: 1 hour agoStatus: Live

Job Summary

Lead Expert in Digital Quality Management leading the transformation of QC digital solutions (QMS, LIMS) with a focus on compliant GxP environments. You will translate requirements into technical specifications, manage the quality product backlog, ensure QA/testing, and drive process optimization, data privacy, and cross-functional collaboration in an Agile setting.

Location: Barcelona

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Sr. Manager level

Key Responsibilities

•Collaborate with stakeholders to analyze user requirements and translate them to functional specifications and technical business impact.
•Execute on the digital quality backlog of enhancements and on the Quality Roadmap to deliver measurable value aligned with digital transformation priorities.
•Define and execute test cases, manage user acceptance testing (UAT), and ensure system usability, reliability, and performance.
•Ensure digital solutions adhere to GxP, data privacy, and security standards.
•Configure and maintain quality-focused business applications (e.g., QMS, LIMS) and provide support for troubleshooting.
•Proactively collaborate with business stakeholders to analyze and optimize processes, promote architectural consistency and reduce technical debt.
•Create, update, and maintain detailed documentation, including user manuals, SOPs, and system design specifications.
•Act as the central point of contact for product-related communication, managing expectations and fostering transparency across all levels of the organization.
•Monitor product performance, gather user feedback, and identify opportunities for innovation and continuous improvement.

Key Requirements

•8+ years of delivering digital solutions within Quality Control (QC) systems and tools such as LIMS and QMS
•Experience with LIMS (e.g., Sample Manager, Labware) and QMS (e.g., Arena, Veeva, Trackwise)
•Strong knowledge of Laboratory and Quality Management systems and business processes (sample management lifecycle, workflow automation, batch management, inspections, audits, CAPA/non-conformance)
•Experience in digital solutioning for Quality Management; configurations and data migrations (including SAP ECC and S/4Hana)
•Good understanding of integrations with other systems (e.g., CDS, SAP modules) and dependencies on processes (Procurement, SHE, Compliance)
•Experience working in Agile environments
•Excellent English communication and stakeholder engagement skills
•Ability to work independently and as part of a team
•Mobility/flexibility for travel

Experience:8+ yearsPharmaLife sciencesLaboratoryGxPQCLIMSQMS

Skills:CommunicationLeadershipProblem-solvingStakeholder managementStakeholder engagement

Languages:English

Tech Stack:LIMSQMSLabwareSample ManagerArenaVeevaTrackwiseSAP ECCS/4HanaCDSSAP modules

Company Brief

DSM

Industry: Chemical Manufacturing

Website

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DSM