Descripción de la oferta
Future Horizons is collaborating with a renowned Italian biopharmaceutical company focused on the development of innovative therapeutic solutions, particularly in the areas of rare diseases, ophthalmology, and biotechnology. The company operates within a highly regulated environment where quality, compliance, data integrity, and patient safety are critical success factors. Solutions such as Veeva Vault play a strategic role in enabling document management, quality governance, compliance, and inspection readiness. Given the increasing complexity of regulatory requirements and the need to maintain validated systems throughout their lifecycle, the client is strengthening its application governance capabilities to ensure business continuity, operational excellence, and alignment with industry best practices. Future Horizons is searching for a Product Owner/Tech Lead Veeva Vault who will support the client in the technical ownership, governance, administration, and continuous evolution of its Veeva Vault platform. The consultant will act as the primary technical reference for the assigned applications, coordinating activities across business stakeholders, IT functions, infrastructure teams, and software vendors. The role will involve managing releases, upgrades, patches, incidents, service requests, user provisioning, licensing activities, and operational support while ensuring adherence to regulatory and company standards. The consultant will also contribute to compliance and validation activities by supporting Computerized System Validation, data integrity controls, cybersecurity requirements, audit readiness, vendor management, and system lifecycle governance. The project focuses on the management and optimization of the Veeva Vault platform, including modules such as QMS, QDocs, Safety Docs, and e TMF. These applications are strategically important for ensuring regulatory compliance, document control, inspection readiness, and quality process execution across the organization. Skills Required Strong experience as Product Owner, Technical Lead, Application Owner, or Platform Manager in regulated pharmaceutical, biotech, or life sciences environments. Extensive hands‑on experience with Veeva Vault, particularly within QMS, QDocs, Safety Docs, e TMF, or related modules. Proven knowledge of Computerized System Lifecycle Management (CSLM) methodologies and best practices. Strong understanding of Computerized System Validation (CSV) processes within Gx P-regulated environments. Experience managing cloud‑based enterprise applications throughout their entire lifecycle. Knowledge of Gx P regulations, data integrity principles (ALCOA+ ), quality systems, and inspection readiness requirements. Experience managing application releases, upgrades, patches, regression testing, and revalidation activities. Strong understanding of Identity & Access Management, user provisioning processes, Single Sign-On (SSO), and licensing administration. Familiarity with IT service management processes including Incident Management, Problem Management, Change Management, SLA monitoring, and CMDB governance. Experience interacting with software vendors, managing technical escalations, contracts, audits, and supplier performance within regulated environments. Work Location: Fully Remote Contract Type: Independent Freelance Consultant (VAT Registered/Self-Employed Contractor) Engagement: Full-Time Duration: Initial 6-month contract, with a high likelihood of project extensions. #J-18808-Ljbffr
