Digital Transformation Expert for Document and Quality Management

hace 3 días


Barcelona, Barcelona, España Galderma A tiempo completo
Unlock the Power of Efficient Document and Quality Management

We are seeking a highly skilled Senior IT Business Analyst to join our team in Barcelona. As a key member, you will play a vital role in ensuring our document and quality management systems meet both business and regulatory requirements.

About Galderma

Galderma is a leading dermatology company with a presence in approximately 90 countries. We deliver innovative, science-based solutions that cater to the diverse needs of consumers and patients worldwide.

Job Overview

This is an exciting opportunity to join our Global Capability Center in Barcelona, where you will have access to global career opportunities and exposure to cross-functional projects.

  • Main Responsibilities:
  • Requirements Gathering and Analysis: Collaborate with stakeholders to gather and analyze functional and technical requirements for eDMS and QMS systems.
  • System Implementation and Optimization: Lead the implementation of eDMS and QMS solutions, ensuring alignment with business goals 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.
  • Process Mapping and Continuous Improvement: Analyze current processes and recommend improvements leveraging eDMS and QMS solutions.
  • Vendor and Solution Evaluation: Evaluate and select eDMS and QMS vendors, considering business requirements and industry standards.
  • Data Migration and System Integration: Lead data migration efforts and ensure integration with other enterprise systems.
  • Training and Support: Develop training materials and provide ongoing support for end-users.
  • Project Management: Coordinate IT projects within the clinical development area.
Requirements

To be successful in this role, you will need:

  • Proven Experience: At least 5 years of experience as an IT Business Analyst specializing in eDMS and QMS within regulated industries (pharmaceutical, biotech, medical devices).
  • Regulatory Knowledge: Strong understanding of regulatory requirements such as GxP, ISO, and 21 CFR Part 11.
  • Technical Skills: Experience with system validation and process optimization in document and quality management.
  • Communication Skills: Excellent communication, stakeholder management, and problem-solving skills.
What We Offer

We offer a competitive salary, estimated at €60,000 - €80,000 per year, depending on your experience and qualifications. Additionally, you will have the opportunity to work with a dynamic team, develop your skills, and contribute to the growth of a leading dermatology company.



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