Quality Manager

The Quality Manager is responsible to support manufacturing and to advise on vendor onboarding, technical transfer and validation. This role will act as a GMP/GDP advisor to the manufacturing and supply team for activities in the US. This role will also provide operational Quality support through QMS oversight and record management. Act as Quality point of contact for US GMP/GDP vendors and ensure requirements within QTA’s are maintained with partners. Provide Quality oversight of GXP vendor qualification, process analytical and shipping validation, non-conformances and changes at vendors, as well as technical transfer and validation activities at partners. Ensure that company Quality related processes are harmonised and standardised to drive compliance and improve efficiency. Responsible to measure and monitor the performance of the QMS. Act as a Quality SME to support the business where required, lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness. Make Risk based Quality decisions, identify, assess, prioritise and address risks and opportunities. Investigate non-conformances effectively and manage risks.