Principal QA Information Systems Engineer

About

Drive quality assurance in innovative healthcare solutions as a Principal QA Information Systems Engineer. Collaborate globally to ensure enterprise systems meet regulatory standards and maintain high data integrity.

In this influential role within the Cell & Gene Therapies team, you'll leverage your expertise in SAP and relevant platforms to support complex business needs and ensure robust compliance. Collaborating with cross-functional teams, you will oversee audits, address deviations, and implement continuous improvements in quality management systems. Your leadership will help deliver life-saving therapies by managing quality processes efficiently.

Key Responsibilities

• Serve as Quality Subject Matter Expert for CGT systems
• Develop and lead data integrity compliance programs
• Manage internal and external audit support processes
• Collaborate for compliance in CGT technologies
• Drive continuous improvement in quality management

Requirements

• Bachelor's or Post-Graduate in Science or Engineering
• 10+ years in quality assurance in pharma or biotech
• Expertise in Cell & Gene Therapy and FDA/EMA regulations
• Strong negotiation and influencing skills across functions
• Excellent communication abilities for complex problem-solving

Champion quality assurance initiatives that underpin revolutionary therapies and ensure data integrity across healthcare technologies.