Aptuit is a company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators, offering a modern business strategy aimed at revolutionizing the entire process, from drug discovery through commercialization.

We are seeking a Director in our Oxford office to join the Quality department. The purpose of the position is to manage all quality issues related to the manufacture of active pharmaceutical ingredients (API) including compliance of the quality management system with current global Good Manufacturing Practices and Good Manufacturing Practice Guide for API, as defined by the International Conference on Harmonisation Q7a.

The key responsibilities of this role are: to manage the Quality Department and provide support for the personal development of the team; to identify, develop, monitor and drive challenging objectives for all functions within Quality to deliver business objectives identifying metrics to report on effectiveness; to prepare and manage the budget for the Quality Department; to act as the main contact of the department, with regard to customer and regulatory authorities and be responsible for planning, hosting and running customer and regulatory audits; prepare, in partnership with the Clients, the quality agreements; lead the internal audit programme and the qualification programme of sub-contractors and key suppliers; provide GMP advice and co-ordinate with Clients, Production and Analytical Departments over process validation activities; take responsibility for the GMP training of personnel involved in cGMP manufacturing of API; assist in the Quality/Documentation elements of ISO14001 inspections with the Environmental Representative.

The ideal candidate must be educated to degree level or equivalent preferably within the pharmaceutical industry. You must have significant knowledge and experience in leading a quality management program, ideally related to the manufacture of active pharmaceutical ingredients (API), including compliance of the quality management system with current global Good Manufacturing Practices and International Conference on Harmonisation Q7a.

A natural leader, the position holder will be able to communicate with staff at all levels and have a robust track record in managing people.

To apply for this position please email your CV and current salary details to careersUK@aptuit.com. Please include the job reference number, the position applied for and the Aptuit facility location.