Description
Clinical Quality Assurance Manager - Cambridgeshire - Pharmaceutical

An exceptional opportunity has arisen for a Clinical Quality Assurance professional to join a world leading Pharmaceutical company who work in one of the most exciting areas of modern medicine based in Cambridgeshire in the South East of England as a Clinical Quality Assurance Manager.

This expanding and highly successful research and development company manufactures Pharmaceutical prescription products in an extensive range of therapeutic areas including oncology, epilepsy and inflammation. This innovative Pharmaceutical Company are at a key point in their development with large scale Phase III Oncology studies currently running with high prospects.

As the Clinical Quality Assurance Manager you will manage the GCP CQA group concentrating on these Phase III studies leading to US FDA NDA approval as well as cover exploratory Phase I and II studies for the products in their research pipeline. You will report to the Director of Quality and have the following responsibilities:

Key responsibilities:
Lead the CQA (Clinical Quality Assurance) audit team and oversee the design and implementation of the audit programme for the Companies Clinical development function, including internal systems, external suppliers, documentation and international investigator site audits,
Provide support, advice, education and training to other departments involved in the company's clinical trials and potentially become involved with cross-functional GMP and GLP audits,
Organise a quality system for introducing assessments for training competency at all operational levels,
Manage quality audits for Pharmacovigilance systems in Phase IV studies and a worldwide marketplace,
host Regulatory Authority GCP and Pharmacovigilance inspections where required and manage the CAPA process to close out,
Provide a strong input into the set up and maintenance of procedures within Clinical Development departments and support the development and audit of licence application dossiers.

The role will require you to have a relevant life science degree, you must have a broad experience in Clinical research and Commercial Pharmacovigilance, and a minimum of 8 years direct GCP (Good Clinical Practice) experience. You must have 3- 5 years Quality Assurance experience in a GXP environment in the Pharmaceutical Industry. A working knowledge of Oncology or Neuroscience would be beneficial. You should have demonstrable experience in team managements and have a full driving licence as approximately 25% travel is required for the position with the UK and overseas. You should have excellent written and verbal communication skills and good IT skills together with exceptional industry knowledge and attention to detail whilst being organised, driven and spontaneous.

This is a unique and exciting opportunity to work within an exception career driven and progressive Company working in a broad based position, providing exposure to all aspects of drug development and offering excellent benefits including competitive salaries, a pension scheme, performance related bonus, health insurance, car allowance and a generous holiday entitlement.

Key Words - QA, Quality Assurance, Audit, Auditor, Auditing, Pharmaceutical, Clinical, GCP, Good Clinical Practice, Quality Manager, FDA, inspections, Biotechnology, Ely, Histon, Cambridgeshire, South East, England, UK

For further information on the role or company please contact myself, Sara Cork at Paramount Recruitment on 0121 616 3464.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Contact emailSara.cork.75435.2362@paramountrecruitment.aplitrak.com