Role 

Manufacturing consulting co-ordinates and leads all compliance (GxP) activities (including SOP and other documentation) for the Company, and in particular for the PC945 project, that is in Phase 3. The company operates via a virtual (fully outsourced) international R&D model, and thus the role holder needs to be able operate effectively in this model to achieve both short-term and longer-term compliance goals.

About you

The position requires at least 15-20 years of experience in QA and compliance, ideally across multiple GxP areas, and at all stages of development. A proven ability to lead and co-ordinate compliance activities through various stages of development is essential, with experience with late stage development through to registration highly desirable. The role requires demonstrated management, organization and leadership skills and the ability to take a risk-based approach to compliance across functions, manage long term goals, and manage a departmental budget. Initially this role will be very “hands on” to further develop Quality Management System. It is desirable that the role holder has experience with either sterile products or inhaled medicines (either novel or generic). The role has a heavy (estimated ~ 70%) CMC/GMP focus, thus an individual with a solid GMP background is required. However the overall compliance of the other functional (pre-clinical, clinical and regulatory) activities is also within the scope of the role.

#LI-Remote 

#LI-LB3