Digital Quality & GxP Manager

About the role

The role supports quality and compliance across a technology-driven research and health services group. It focuses on managing GxP risk and giving practical quality guidance throughout the software product lifecycle.

What you will do

• Approve and review validation work for software and AI products against regulations and internal policy
• Prepare for external regulatory audits and lead internal or vendor audits on GxP compliance
• Build and maintain the digital and software parts of quality management systems, including for AI
• Monitor systems and processes for adherence to procedures, audit standards and industry practice
• Assess key vendors against digital quality requirements and train colleagues on quality processes

What they look for

• Proven leadership running compliance programmes in the software industry
• Hands-on experience with Good Clinical Practice
• Experience with SaaS applications and agile product development methods
• Strong analytical, communication and organisational skills with close attention to detail
• Understanding of data management in healthcare or clinical trials
• At least three years of experience implementing compliance work

Nice to have

• Project management experience
• Certification in GxP quality, computer systems validation or quality systems management