Senior QA Manager - Clinical Trials
- Experience Level
- Experienced (non-manager)
An excellent opportunity to join Richmond Pharmacology, the UK’s largest early Phase Contract Research Organisation (CRO) based in central London. We conduct early phase healthy volunteer and patient clinical trials for our pharmaceutical clients to help in the development of innovative medications. Our experienced and world-renowned teams and our global reach contribute to making Richmond Pharmacology an exciting and dynamic place to work.
We are recruiting for a Senior Quality Assurance Manager to join our QA team and contribute to our important work while expanding their existing skills within the clinical pharmacology sector.
This is a permanent role working over a 40-hour week and will report to the Executive Board.
You must have the ability to direct and oversee the QA activities at Richmond Pharmacology to ensure the delivery of quality documents, processes and data to our global client base using GCP compliant processes. You must be able to work in a fast-paced working environment, prioritise effectively, and ensure compliance with regulatory standards including SOPs, ICH-GCP and other guidelines.
Key Skills & Responsibilities:
• Up to date knowledge of clinical trial regulations and guidelines.
• Ensure all operational processes are compliant with regulations.
• Provide appropriate QA responses to client’s queries.
• Responsible for training and development of QA staff.
• Responsible for updating all staff with changes in regulation.
• Responsible for overall management of Quality Management System.
• Responsible for scheduling and management of client and regulatory audits.
• Responsible for ensuring timely internal and external audits.
• Responsible for ensuring follow up of audit and issue CAPA's.
• BSc or other relevant degree
• QA Qualification preferable
• A minimum of 10 years’ GCP experience within academia or industry, at least 5 at a senior level
• Auditing clinical trials to international GCP standards is essential
• Advanced level of knowledge of all relevant industry guidance and standards (e.g. FDA, EMA, ICH, PMDA)
• Evidence of implementation of new processes and information in relation to best practices and standards, as well as emerging pharmaceutical industry guidance, enabling our QA processes to remain leading edge and competitive
• Strong written and verbal communication skills to clearly articulate QA requirements to various audiences.
• Driven, persuasive and able to influence and have an impact at all levels of the organisation.
• Experience and ability to manage QA activities and effectively liaising with sponsors, other CROs and service providers.
Tasks & Responsibilities
• Recruit, manage and develop entry level to senior team members to ensure quality of early phase clinical trial projects within Richmond Pharmacology
• Liaise closely with Principal Investigators, internal clinical and operational teams, pharmaceutical sponsors, regulatory authorities and other stakeholders
• Ensure effective and efficient scientific standard operating processes are implemented and maintained in order to meet all regulatory requirements for all studies
• Drive collaboration and innovation within the QA team as well as cross-functionally by interacting with other departments and externally
• Provide essential quality assurance (QA) training to the operational teams at Richmond Pharmacology
• Ensure inspection readiness is maintained
In return, we offer a competitive remuneration package, including life assurance (3 x salary), private single medical and dental insurance and a generous holiday allowance, starting at 25 days, excluding bank holidays, increasing by 1 day per annum, up to a maximum of 30 days.
To apply, please follow the link which will take you to our BambooHR site. You will be asked to supply a copy of your CV and some basic contact details.
We endeavour to respond to all applicants, but this is not always possible due to the high volumes of applications that Richmond Pharmacology receives on a daily basis. If we do not get back to you directly within two weeks of your application, please accept our apologies and assume that you have not been successful on this occasion.