CMDL Quality Lead (Fixed Term)

Applications are invited for a Quality Lead who will be based in the Cancer Molecular Diagnostics Laboratory (CMDL), Clifford Allbutt Building, Hills Road, Cambridge. The post holder will provide leadership on all issues related to GCP and ISO laboratory quality management system.

The CMDL is a key strategic resource for the integrated cancer medicine programme aimed to translate innovative genomics methods for advanced diagnosis and clinical management of cancer at the Cancer Research UK Cambridge Centre, funded by NIHR-BRC and CRUK CC Integrated cancer medicine theme. crukcambridgecentre.org.uk/research/strategic/cancer-molecular-diagnostics-lab.

The post holder is required to be educated to degree level or equivalent in a life science related subject and have an in-depth knowledge of GCP, GCLP, HTA and ISO 15189:2022 regulatory requirements. Ideally, they will have experience working in a quality assurance setting maintaining a quality management system, as well as experience working in a regulated GCP/ISO service laboratory with clinical trial samples. The post holder will work closely with the Laboratory Director and Senior Scientific Staff and will be responsible for maintaining and monitoring the regulatory compliance of the laboratory to the above standards and overseeing the associated quality management system. They will manage and be administrator for the Quality Management Information System (Ideagen, previously Q-Pulse), oversee the controlled introduction of new procedures, take on the role of Archivist and maintain an internal and external auditing programme to identify areas of regulatory risk. The postholder will be responsible for establishing departmental quality meetings including an Annual Quality Management Review. The post-holder will provide guidance and advice to staff and customers on all aspects of GCP/ISO compliance and assist in the production of remedial action plans as necessary. The successful candidate will also work closely with Quality Leads and Clinical Trial Coordinators` at the Cambridge Clinical Trials Unit. Training opportunities in quality assurance will be provided, along with opportunities to shadow senior staff in the Cambridge Clinical Trials Unit. The successful candidate will also have opportunities to complete an online Health and Safety course as appropriate for the role.

The NIHR-BRC funding supporting this position is available until 31^st March, 2027 in the first instance.

Any queries regarding this position should be directed to Dr. Shubha Anand, CMDL Director sa263@medschl.cam.ac.uk

Fixed-term: The funds for this post are available until 31^st March 2027 in the first instance.

This appointment requires a Research Passport application.

To apply online for this vacancy and to view further information about the role, please visit: www.jobs.cam.ac.uk/job/48313.

Please ensure that you upload a covering letter and CV in the Upload section of the online application. The covering letter should outline how you match the criteria for the post and why you are applying for this role. If you upload any additional documents which have not been requested, we will not be able to consider these as part of your application.

Please include details of your referees, including email address and phone number, one of which must be your most recent line manager.

Date of interview: 4^th or 7^th October 2024

Please quote reference RD43269 on your application and in any correspondence about this vacancy.

The University actively supports equality, diversity and inclusion and encourages applications from all sections of society.

The University has a responsibility to ensure that all employees are eligible to live and work in the UK.

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