Validation Manager

• Develop and document validation strategies for complex projects considering both business needs and regulatory requirements (GxP FDA etc.).
  
• Define and implement validation approaches to meet project specifications collaborating with the clients internal Quality department.
  
• Champion the One Medicine Platforms adoption of the DevOps Model within the validation framework.
  
• Lead and coordinate the validation process effectively communicating and negotiating deliverables with stakeholders.
  
• Prioritize tasks and manage time effectively to ensure timely project completion.
  
• Present and defend validation concepts to compliance offices and regulatory authorities during audits and inspections.
  

Requirements

• Bachelors or Masters degree in IT engineering sciences pharmaceuticals biotechnology or a related field.
  
• Strong understanding of analysis and user requirement engineering methods.
  
• Excellent written and verbal English communication skills.
  
• Experience in project implementation using computer validation regulations and methods (SOPs GCP FDA Guidelines CFR 21 Part 11) and data integrity principles.
  
• Passion for teamwork and fostering collaboration in diverse technical and cultural environments.
  
• Prior experience with Agile methodologies is a strong asset.