About the Role:
Quality Director (GMP, GLP, QMS)
Quality Director (GMP, GLP, QMS) Role and Company Overview:
A leading Cell therapy based biopharmaceutical company is looking for a Quality Director to take overall ownership of the development of a new Quality Management System (QMS) as they transition their new build site into a Pharmaceutical manufacturing organisation. Focusing on cutting edge research and products, you'll liaise with a passionate and committed team, building up a new team of your own.
Based in their UK site in Oxfordshire, you'll be work with the global sites to drive the Quality teams forward as they develop the manufacturing of their innovative products. This is an exciting new stage of the company's progress, and you'd be at the forefront, spearheading the successful development.
Reporting to the Vice President of Quality in the USA, you'll work autonomously, overseeing and monitoring Quality standards with particular focus on development and technology transfer.
As Quality Director, you'd employ your experience from both GMP and GLP to deliver training and review relevant documentation. A flexible and adaptive working style will be crucial as you'll be the primary point of contact for Quality in the UK, and will need to employ your analytical skills to solve any complications.
- At least 5 years' experience within Quality, preferably Pharmaceuticals
- Experience working within both a GMP and GLP environment
- Clear communicator and strategic thinker
- Experience working with QMS, preferably implementing and developing
- Flexible and adaptive working style
- Experience of Corrective and preventive action (CAPA)
- Experience of SOPs
- Experience in leading audits
- Eligible to be nominated as the Qualified Person
- Experience within Biologics
Location: Oxfordshire, UK, as well as 10% travel to both Europe and the USA
Start date: ASAP
If you would like to express interest, please get in touch with a copy of your latest CV, detailing your experience within the areas above and call in for Dan Abbott to discuss the application process