Head of Quality Assurance

Head of Quality Assurance

Location: Wiltshire

CPL Life Sciences are working with a pharmaceutical company focused on manufacturing and providing R&D services for product development. They are looking to recruit a Head of Quality Assurance who will be fully responsible for the Quality Systems and ensuring that they are compliant. The post holder will report into the Director of Quality and have line management responsibilities.

Key responsibilities:

• Leading the QMS and Compliance teams to deliver compliant Quality systems, and develop a world–class QMS
• Providing operational leadership and direction to a large team
• Developing and managing the QA, GMP, and QMS programmes, policies, standards, and procedures
• Leading and supporting where required with regulatory inspections
• Overseeing GMP Quality system performance metrics, analysing compliance data and coordinating the necessary Quality reporting and escalation responses
• Managing the processes for the Quality Management Review Board, Change Control Review Board and Risk Management forums
• Providing expertise and guidance to senior management on global GMP regulations, ICH guidelines and internal policies and procedures
• Assisting with the creation/revision of SOPs, Code of Practices, Policies and Key Quality documents
• Training, managing, and mentoring QMS, GMP, and QA staff

Requirements:

• Extensive GMP QA experience within an FDA/EMA regulated environment
• Experience managing a team of QA professionals
• Excellent knowledge of cGMP regulations; validation standards; QMS; FDA/EU/ICH guidelines and quality risk management principles

If you would like to hear more, please apply within or send your CV to