Quality Assurance Manager
Quality Assurance Manager
Job ID: 009284
Salary: £38,304-£45,026 per annum
Closing date: 29-Nov-2020
Business unit: Faculty of Life Sciences & Medicine Department: Comprehensive Cancer Centre
Contact details: Michelle Sleeth, firstname.lastname@example.org
Professional and support services
Please note this post is remote working until otherwise directed by the King's Return to Campus Plan. The contract is fixed term until November 2021 as a maternity cover.
An exciting opportunity has arisen to join Professor Sasieni's Cancer Research UK & King's College London Cancer Prevention Trials Unit (CPTU) as a QA Manager. The CPTU is part of the Cancer Prevention Group, within the School of Cancer and Pharmaceutical Sciences based at the Guy's Campus. One of only eight CRUK-funded trials units, CPTU specialises in research to advance cancer prevention, early diagnosis and screening.
Our portfolio of both secondary (hospital) and primary (community) care trials includes:
- Multi-centre international randomised controlled trials of medicinal prevention of cancer often using drug repurposing;
- Pragmatic trials of screening and diagnostic interventions;
- Trials of behavioural interventions in cancer prevention and screening;
- Trials of diagnostic/screening devices;
- Long-term follow-up of participants;
- Bio-specimen collections for biomarker discovery and validation.
The post holder will have overall responsibility for the Quality Management System (QMS) of the CPTU, ensuring it is compliant with sponsor requirements as well as national and international standards for the conduct of clinical research. As a member of the CPTU team, the QA Manager will have broad governance responsibilities including:
- Maintaining a robust QMS that meet needs of our varied portfolio of studies
- Monitoring compliance with UK regulations
- Overseeing and implementing the unit's audit plan
- Supporting information governance processes
You will be required to have an in -depth understanding of the UK policy framework for health and social care research, the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) and experience in Quality Assurance (QA) within a clinical research environment, ideally in an academic environment or clinical trials unit. You will also have experience of developing standard operating procedures (SOPs). The successful candidate will need a flexible approach to their duties, possess excellent written and verbal communication skills, and be able to work both independently and as part of a team.
You will work closely with the Peter Sasieni, the director of the CPTU, the Head of Operations and other project-specific trials staff.
Review, implement and maintain the clinical trial Quality Management System (QMS) including:
- Oversee the authorship and approval process, version control for all SOPs ensuring compliance with current regulations
- Examine operating procedures to ensure the process and the product meet regulatory standards and implements changes necessary to ensure compliance
- Examine current operating procedures to determine how quality may be improved
- Dissemination, review and acknowledgement of CPTU SOPs
- Review of the current portfolio of SOPs identify where additional SOPs are needed
- Liaise with all staff in the CPTU to ensure that the requirements of the SOPs are incorporated within daily working practice
- Review and continual improvement of the CPTU process for SOP management
Manage the CPTU non-conformity/incident reporting process including:
- Work with senior members of the CPTU core team to ensure all non-conformities are reported, action plans developed e.g. Corrective And Preventive Actions (CAPA) report and executed within appropriate timeframes. This may require collaborative working with different internal and external stakeholders.
- Manage the development and delivery of a CPTU audit programme including:
- Develop and maintain an audit plan for the CPTU
- Undertake internal and external, project and systems audits to ensure compliance with SOPs
- Act as first point of contact or external audits/inspections; including the production of documentation
- Work with senior members of the CPTU core team to identify, agree and implement any action plans identified from either internal or external audits within agreed timeframes
- Maintain accurate and up to date records of all incidents and non-conformities reported
- Feedback constructively to trial teams on any findings at audit and be able to support colleagues to achieve excellence in quality.
- Have a good understanding of current regulations governing the conduct of trials as well as GCP
- Establish and maintain links with QA Managers at other CTUs to ensure that there is effective liaison and sharing of best practice
- Ensure that monitoring requirements for each clinical trial protocol are assessed. Ensure that appropriate monitoring is conducted and review monitoring reports.
- Assist, and when required take a lead, on the preparation and review of reports, inspection dossiers and other formal written documentation.
- Lead the delivery of training (e.g. GCP, Quality Management, Regulatory Framework) to unit staff and general knowledge dissemination
- Engage in appropriate professional activities to keep knowledge base and skills up to date
- Support: Information Governance processes in the Cancer Prevention Group and CPTU
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge & experience
- Proven experience in either Quality Assurance and/or clinical trials
- Experience in the development and maintenance of quality management systems associated with the delivery of clinical trials
- Knowledge of Good Clinical Practice, Information Governance, The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) and amendments, and regulatory reporting requirements.
- Evidence of working in a research environment and a solid understanding of the current regulatory environment
- Ability to produce appropriate standard operating procedures and implement them
- Experience of examining operating procedures to ensure the process and the product meet regulatory standards and experience implementing changes necessary to ensure compliance.
- Knowledge of relevant legislation and its impact upon specification requirements
- Experience of managing varied workloads and evidence of ability to prioritise own workload
- Excellent organisational, written, verbal communication and interpretation skills as well as a strong capacity to troubleshoot
- Experience of advising and influencing at a senior level
- Previous experience of working in an academic environment/Clinical Trials Unit within the Quality Assurance field
- Experience of conducting both project and systems audits
- Proven track record or working collaboratively with a range of specialists including statisticians, pharmacists, health economists
- Experience of MHRA inspections and other audits
This post is subject to Disclosure and Barring Service and Occupational Health Service.