Senior It Business Analyst – Edms And Qms

hace 2 meses

Barcelona, España Galderma A tiempo completo

Job Title: Senior IT Business Analyst – eDMS and QMS Location: Barcelona

Job Description We are looking for a Senior IT Business Analyst with expertise in electronic Document Management Systems (eDMS) and Quality Management Systems (QMS) to join our team. In this role, you will play a crucial part in ensuring our document and quality management systems meet both business and regulatory requirements. The ideal candidate will have extensive experience in IT solutions for document and quality management within a regulated environment, such as pharmaceuticals, biotech, or medical devices.

Key Responsibilities Requirements Gathering and Analysis for eDMS and QMS Collaborate with business stakeholders to gather, analyse, and document functional and technical requirements for eDMS and QMS systems. Translate business needs related to document lifecycle management, quality control, and compliance into clear, actionable IT specifications. System Implementation and Optimization Lead or support the implementation of eDMS and QMS solutions, ensuring alignment with business goals, industry standards, and regulatory requirements. Propose and drive optimization initiatives for existing document and quality management systems to enhance efficiency, usability, and compliance. System Validation and Compliance Ensure all eDMS and QMS systems meet regulatory standards such as GxP, ISO, and 21 CFR Part 11. Lead system validation activities, including user acceptance testing (UAT) and creation of validation documentation. Stakeholder Management and Communication Serve as the primary liaison between IT, quality assurance, regulatory, and business units to ensure eDMS and QMS solutions meet all stakeholder requirements. Facilitate workshops, meetings, and presentations to align stakeholders on project goals, timelines, and system capabilities. Process Mapping and Continuous Improvement Analyse and document current document management and quality control processes, identifying areas for improvement. Recommend and implement process changes leveraging eDMS and QMS solutions to enhance productivity, compliance, and audit readiness. Vendor and Solution Evaluation Evaluate and select appropriate eDMS and QMS vendors, considering business requirements, industry standards, and system compatibility. Manage relationships with external vendors and consultants to ensure timely delivery of solutions. Data Migration and System Integration Lead or support data migration efforts, ensuring a smooth transition from legacy systems to new eDMS and QMS platforms. Ensure integration of eDMS and QMS with other enterprise systems such as ERP, LIMS, and CRM. Training and Support Develop training materials and lead training sessions for end-users to ensure proper utilization of eDMS and QMS systems. Provide ongoing support for business teams in troubleshooting and optimizing system performance. Project Management Coordinate IT projects within the clinical development area, ensuring timely and within-budget delivery. Identify and mitigate project risks, maintaining a proactive approach to problem-solving. Continuous Improvement Stay informed about new technologies, industry trends, and regulatory changes impacting clinical development. Propose innovative IT solutions to enhance clinical trial efficiency, data integrity, and patient safety. Risk Management and Audit Readiness Identify and mitigate risks related to eDMS and QMS implementations, ensuring system stability and compliance. Ensure systems are audit-ready and support regulatory inspections by maintaining up-to-date documentation and validation records. Skills & Qualifications Proven experience as an IT Business Analyst specializing in eDMS and QMS within regulated industries (pharmaceutical, biotech, medical devices). Strong understanding of regulatory requirements such as GxP, ISO, and 21 CFR Part 11. Experience with system validation and process optimization in document and quality management. Excellent communication, stakeholder management, and problem-solving skills. Experience with the implementation or maintenance of eDMS/QMS platforms (e.g., OpenText, Veeva Vault, MasterControl, Sparta TrackWise). Fluent in English (both written and spoken). Soft Skills: Excellent analytical and problem-solving abilities, strong communication and interpersonal skills, leadership qualities, and the capacity to build and maintain customer relationships. Knowledge of cloud-based document and quality management solutions. Business Analysis certifications (e.g., CBAP, CCBA) or Project Management certifications (e.g., PMP, PRINCE2) are a plus.

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