£70,000 - £80,000 DOE
2 months ago
Associate Director, QA
We are currently working with a leading speciality pharmaceutical company, who are based in Cambridge, responsible for developing innovative drugs for anaesthesia and critical care. They are looking for an Associate Director, Quality Assurance to be responsible for supporting and assisting the growth of the Quality team as well as other departments within the business. They will be responsible for managing the QMS, batch reviews and the document control system.
- Line Management of Quality Assurance Associates and administrators
- Conducting and being the sole point of contact for both internal and external audits
- Maintain and manage Quality agreements with suppliers and other third party organisations, including writing, review and approval.
- Manage CMO’s and contract laboratories.
- QA review and approval of documentation.
- Minimum 5 years’ experience of working within Quality, in a Pharmaceutical or Research organisation.
- Experience of working with MHRA/FDA/ICH and working closely to their guidelines.
- Experience of maintenance of QMS
- Deviation/CAPA writing, investigation and approval
- Strong auditing experience and knowledge of leading audits.
If this could be something you would be interested in discussing further, please apply now with a copy of your CV and one of our consultants will reach out to discuss!