Quality Assurance - Glasgow, United Kingdom - University of Glasgow

Description

Job Purpose

To lead the strategic planning and development of the Good Clinical Laboratory Practice (GCLP) level processes, including Quality Assurance and Quality Control, for clinical trial analyses carried out by the School of Cancer Sciences.

This covers all GCLP aspects of the Translational Pharmacology Laboratory, based at the WWCRC, the GTRF based at the Queen Elizabeth University Hospital and the Paul O'Gorman Laboratory based at Gartnavel Hospital.

This position will involve working with the laboratory teams at all 3 sites to establish all necessary quality aspects of a GCLP laboratory for clinical trials support.

The Translational Pharmacology Laboratory includes the Cancer Research UK (CRUK) Centre for Drug Development (CDD) Biomarkers Hub and supports the laboratory analyses performed by the Glasgow Adult Experimental Cancer Medicine Centre (ECMC).

Main Duties and Responsibilities 1.

Responsible for leading the delivery of all GCLP aspects of relevant projects within SCS and within agreed timescales, budgets, and scope to maximise service quality, efficiency and continuity.

2.

Lead the formulation of strategy for a Quality Management System (QMS) that meets GCLP guidelines as a minimum standard, and take responsibility for planning, implementing, and maintaining the QMS.

3.

Develop costings for the above as required to support overall budgetary management of the group, ensure delivery of the QMS within budget and provide recommendations for ongoing resource requirements, under the direction of the individual laboratory group leaders.

4.

Management of clinical laboratory staff resources, under the direction of the individual laboratory heads, providing:

support, leadership and direction; developing plans for the delivery of required work and allocating the work according to resource type required, availability and skills; monitoring progress of work against plan, evaluating alternatives and initiating corrective action when required.

5. Responsible for internal audits and external audits of suppliers, as necessary. 6.

Lead organisation and preparation for an independent inspection to confirm the standards laid out by GCLP are met and address findings from this and future inspections/audits.

7.

Be responsible for carrying out Corrective and Preventive Action (CAPA) processes, supplier management, customer service and record control within the QMS.

8. Cover quality assurance aspects of additional processes, such as risk management, as required. 9.

Keep up to date with the regulatory requirements of all laboratory techniques across all 3 sites associated informatics analyses, as well as the latest methods in quality management to provide strategic input.

10. Provide training, supervision and support to research staff and students to facilitate compliance with the QMS. 11.

Apply professional expertise and leadership to develop a strategy for implementation of a streamlined LIMS systems over the 3 sites.

12. Instigate a program of corrective actions, validations, documentations, stability etc in order to monitor the quality system.

Collect, analyse, and summarise information and trends on these measures in order to prepare reports on the performance of the group.

13.

Act as a point of contact for the CRUK CDD Biomarkers Hub team for QA / QC and GCLP, including meetings with the CRUK CDD 14.

Act as the representative for QA / QC / GCLP on behalf of the Glasgow ECMC at ECMC Network initiatives or as part of the ECMC North Biomarkers group 15.

Work closely with colleagues in the MVLS Centre of Excellence for Trails Collaboration (CETC). 16. Engage in reasonable professional development activities as appropriate. 17. To contribute to the enhancement of the University's international profile in line with the University's strategic plan.

Knowledge, Qualifications, Skills and Experience Knowledge/Qualifications Essential:
A1.

Scottish Credit and Qualification Framework level 11 or 12 (Post Graduate or PhD Qualification), or equivalent (including professional accreditation with relevant formal training), and experience of personal development in a similar or related role(s).A2.

Formal quality management qualification (e.g. BSI/UK Accreditation Service qualified assessor, internal/lead auditor or equivalent).A3. Thorough knowledge and understanding of GCLP guidelinesA4.


Operational knowledge of accreditation Desirable:
B1. A working knowledge of the Human Tissue ActB2.

Previous experience in one of the following techniques:
immunohistochemistry; ctDNA / cfDNA analysis; next-generation sequencing; immuno-assays; ELISAsB3.

Previous experience with risk management Skills Essential:
C1. Excellent organisational and time-management skillsC2. Excellent communication skills, including public presentations and ability to communicate complex concepts clearly and conciselyC3. Strong cross-discipline collaborative ability and the ability to interact with individuals with a wide variety of expertiseC4. Highly motivated with the ability to pro-actively identify problems and present solutionsC5. Extensive IT and data analysis/interpretation skills including ability to analyse and present datasets derived from the QMS, e.g. compliance statistics, trend analysisC6. Excellent interpersonal skills including team working and a collegiate approach.
C7. Willingness and aptitude to work in a multidisciplinary environment.
C8. Problem solving skills including a flexible and pragmatic approach.
C9.

Ability to show leadership skills as appropriate Desirable:
D1.

Demonstrated ability to promote awareness of and roll out a Quality Management System within a workgroup Experience Essential:

E1.

Demonstrable ability to undertake the duties associated with this post, through having acquired the necessary knowledge and skills in a similar role or roles.

E2. Previous experience of implementing a QMS in line with GCP/GLP/GCLP, ISO 15189, ISO 9001 or ISO 17025E3. Experience preparing material for external audit by a regulatory bodyE4.

Experience conducting internal and external audits Desirable:
F1. Experience in laboratory techniques that are utilised in biomarker studies (e.g.immunohistochemistry; ctDNA / cfDNA analysis; next-generation sequencing; immuno-assays; ELISAs)F2. Experience of quality assurance for software e.g EN 62304, ISO 13485F3. Experience working within a healthcare environment, in a clinical trial setting, or in a near-patient laboratory research environmentF4. Experience of electronic QMS e.g. QPulseF5. Experience in LIMS systems Terms and Conditions Salary will be Grade 8, £48,350 - £56,021 per annum. This post is full time (35 hours per week) and has funding available until 30th April 2027.