Senior IT Business Analyst

hace 2 semanas


Barcelona, Barcelona, España Galderma A tiempo completo
About the Role

We are seeking a highly skilled Senior IT Business Analyst to join our team at Galderma. As a key member of our clinical development area, you will play a crucial role in ensuring our document and quality management systems meet both business and regulatory requirements.

Key Responsibilities
  • Requirements Gathering and Analysis: Collaborate with business stakeholders to gather, analyze, and document functional and technical requirements for eDMS and QMS systems.
  • System Implementation and Optimization: Lead or support the implementation of eDMS and QMS solutions, ensuring alignment with business goals, industry standards, and regulatory requirements.
  • System Validation and Compliance: Ensure all eDMS and QMS systems meet regulatory standards such as GxP, ISO, and 21 CFR Part 11.
  • 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.
  • Process Mapping and Continuous Improvement: Analyze and document current document management and quality control processes, identifying areas for improvement.
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).
About Galderma

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.



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