Senior Digital Compliance Expert (m/f/d) - Expert 2

Manager : Laura VetschRecruiter:Clelia LiberatoreDepartment: HC-GM-BVDE CSV & ComplianceLocalisation: Corsier-sur-Vevey | Route de Fenil Z.I.B. Your role :We are looking for a Senior Digital Compliance Expert who wants real ownership, visible impact, and the autonomy to drive critical compliance topics in a GMP-regulated environment.Digital is one of the most dynamic and fast-growing areas in our environment, and the compliance framework around it is still being shaped. This role offers the opportunity to take real ownership in that space - building, strengthening, and raising the standard of digital compliance where it matters most.This role is for someone who combines strong compliance & CSV expertise, especially in investigations, with leadership, sound judgment, and the resilience to perform in high-stakes situations.Lead and strengthen deviation investigations, including impact assessment, root cause analysis, documentation quality, and robust CAPA definitionMaintain the validated status of computerized and automated systems, including periodic reviews and qualification activitiesInitiate and coordinate Change Control Processes and associated risk assessmentsSupport audit and inspection readiness and act as SME when requiredRaise the standard of compliance deliverables, ensuring they are clear, focused, and inspection-readyDrive continuous improvement in compliance processes, data integrity, and operational quality practicesInfluence cross-functional stakeholders and help shape the right quality decisions Who you are:Proven compliance experience in a biopharma or similarly regulated environment, with strong hands-on expertise in investigationsSolid knowledge of GMP / CSV requirements, with strong practical knowledge of computerized system lifecycle management and risk-based validation approaches (e.g. GAMP 5), including validation of complex automated and manufacturing systems. Good practical understanding of GMP computerized or automated systems (such as DCS/SCADA, MES, ERP/SAP, historians or laboratory systems) and biopharma manufacturing processesStrong leadership presence and the ability to influence credibly in a matrix environmentAn excellent mindset: resilient, collaborative, accountable, and solution-orientedClear, concise communication and the ability to bring structure to complex topicsFull professional fluency in French and EnglishWhy this role is worth takingThis is a high-responsibility role with real visibility, meaningful ownership, and the opportunity to make a tangible difference. You will be trusted, empowered, and expected to use both well.