Senior IT Business Analyst

hace 4 semanas

Barcelona, Barcelona, España Galderma A tiempo completo
Job Title: Senior IT Business Analyst - eDMS and QMS Expert

Galderma is a leading dermatology company that delivers innovative, science-based solutions for the skin. We are seeking a Senior IT Business Analyst with expertise in electronic Document Management Systems (eDMS) and Quality Management Systems (QMS) to join our team.

Key Responsibilities:
  • Collaborate with business stakeholders to gather, analyze, 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.
  • 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.
  • Ensure all eDMS and QMS systems meet regulatory standards such as GxP, ISO, and 21 CFR Part 11.
  • 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.
  • Analyze 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Requirements:
  • 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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