Director of Quality

Our client is a CDMO operating across the globe to offer integrated solutions to businesses. They are a customer focussed organisation with them maintaining place at the heart of their mission. 

This business is looking for a highly experienced Quality Director to join the team and drive positive change across the Quality division. You will develop the Quality Operations according to regulation with strong leadership and poignant direction. 

This opportunity allows the successful candidate to work directly with the EU Quality team to effectively implement business goals and processes. 

Key Responsibilities: 

• Collaboration with Site Leadership team and department heads
• Review and set international cGMP standards
• Host regulatory audits 
• Escalate all compliance issues to EU Quality Director 
• Manage Quality Management Review process 
• Lead improvements of processes 
• Ensure compliance with requirements of ICH Q10

What you need: 

• Experience implementing a quality strategy in line with business goals 
• Excellent knowledge of Global, EU and UK pharma regulatory policies
• Extensive people leadership experience, managing large teams 
• Degree in relevant scientific/technical discipline
• Ability to act as a QP
• Knowledge of QA systems in pharma
• Experience hosting MHRA, FDA, customer audits, CI programmes, reg affairs and validation

Please contact - alice.bryce@umbilical-life.com if you have the relevant experience for this position.