Head Of Clinical QA, London
A Head of Clinical Quality Assurance is required for a permanent position with a successful and expanding international pharmaceutical company, to be based at their offices in London
As Head of Clinical Quality Assurance you will provide strategic direction, leadership and management for all aspects of QA activities in support of early phase studies being carried out in the EU and US.
Specific duties will include:
- Developing and maintaining the Quality Management System to ensure it is fir for purpose and that all QA activities are actively managed and resourced
- Ensuring the department's staff and motivated to contribute and achieve targets and objectives and to train and ensure awareness of quality standards, GCP and GMP
- To lead and coordinate regulatory inspection preparation activities and host internal audits and regulatory inspections
- Keeping up to date on relevant GxP regulations, guidelines and principals and advise on their use and compliance
- Line management of a QA team, including managing professional development, performance appraisals, evaluating training needs and mentoring
QUALIFICATIONS As Head of Clinical Quality Assurance, you will require the following:
- BSc / BA degree in science, or nursing qualification
- Proven clinical trial experience and a strong knowledge of SOPs
- Extensive QA experience and previous leadership of a QA department
- Excellent knowledge of current GCP, GMP, cGLP and CFR21 Part II regulations and guidelines
- Experience of performing audits of Investigator site, protocols, clinical study reports, Trial Master Files and Vendors
HOW TO APPLY For more information or to apply for this Head of Clinical Quality Assurance position please contact Jim Gleeson on +44 (0)1438 842973 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37183 in all correspondence.