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QA Director (Global) (Ref: MJ4592)
Ethical Pharmaceutical
UK
On application
Clinical QA
Background
Our client is a Pharmaceutical development and manufacturing organisation focused in the Biologics Market. They currently have an exciting opportunity to head up three manufacturing sites globally.
Reporting to the Head of Quality and Technical Services the incumbent will lead the Quality Assurance (QA) requirements across the Group via a team of direct reports located in various countries across the world. The role will manage and develop the approaches in adherence to company Quality Management Systems (QMS), ensuring consistent compliance to regulatory requirements and that the overall business remains compliant.
Key Responsibilities
1. To ensure that the operational sites remain cGMP complaint at all times by critical management of the direct team and wider Quality Assurance departments.
2. To synchronise current Quality Assurance approaches that exist in each site location to deliver a consistent strategy that meets both Regulatory and business needs and is also in-line with the developing Group Quality Management System.
3. To advise key stakeholders on pertinent quality standards and practices and direct the Quality group in implementing, conducting and/or coordinating GxP auditing/inspection strategies and procedures.
4. To provide a Quality Assurance service which includes product release, auditing, documentation control, training and other QA activities to support cGMP manufacturing operations.
5. To serve as the key driver in preparation for cGMP agency inspections.
6. Fully accountable for preparing and controlling relevant quality assurance budgets, ensuring on-going accurate forecasting