Principal QA Information Systems Engineer
F. Hoffmann-La Roche Gruppe
About the role
About
Elevate healthcare as a Principal QA Information Systems Engineer in Gene Therapy. Ensure quality oversight and compliance of enterprise systems while driving innovative solutions for personalized treatments.
In this pivotal role, you'll serve as the Quality Subject Matter Expert for CGT ERP systems. Collaborate with global teams to design and maintain systems that meet stringent regulatory standards. Your expertise will help translate complex business needs into streamlined processes, ensuring data integrity and compliance with evolving global regulations.
Drive quality and innovation in gene therapies to enhance patient outcomes.
Responsibilities
- Serve as Quality Subject Matter Expert for CGT systems
- Collaborate with global teams for system design and deployment
- Translate business needs into user requirements and process flows
- Develop and implement a comprehensive data integrity program
- Support audits and manage quality records and deviations
Requirements
- 10+ years in quality assurance within pharma or biotech
- Deep knowledge of GxPs, FDA/EMA regulations
- Expertise in Cell & Gene Therapy processes
- Strong communication and influencing skills
- Proactive attitude with problem-solving capabilities
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