Quality Assurance Director

Director of Quality - Biotech - Cambridge

This role is within Biologics and my client are looking to bring on board an experienced Quality Director.

The successful candidate will lead the Biosciences small molecule Quality team and be responsible for the implementation of a fit for purpose Quality Management Framework (QMS) to support the Corporate goal of creating a quality-driven culture.

You will also develop and expand the framework from the current cGMP framework to cover all GXP regulations.


, Ensure that the quality assurance plan supports the corporate strategy in alignment with regulations and standards

, Implement a highly effective quality assurance plan that fully addresses quality assurance and controls, that enables the corporate goals of producing high-quality and safe pharmaceuticals

, Ensure the implementation and the maintenance of standard procedures describing quality systems required for GXP compliance such as but not limited to the following systems: Change Management, Deviation and Investigation of quality incidents, CAPA program Product Release, Validation program, Training program, Documentation control, Complaint Handling, Product Recall


, A Bachelor's or more advanced degree in biochemistry, chemical engineering or related scientific discipline

, A min of 15 years of QA/QC experience in across the GXP disciplines within the biotechnology industry, with a minimum of 8 years of managerial experience in a quality capacity

, Must be a demonstrated self-starter and team player with strong interpersonal skills

, Must have demonstrated leadership skills

For further information please contact Paul Shaw at Blackfield Associates on 02392 322 354 or e-mail paul@blackfieldassociates.com

STR Limited is acting as an Employment Agency in relation to this vacancy.

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