This is IXICO
One business, one mission: improving brain health through the application of digital technologies.
Established in 2004 and listed as a public company in October 2013, IXICO has established itself as a trusted partner to the global biopharma industry, providing technology-enabled speciality services. Our neuroscience expertise in image data management and analysis provides specialist data analytics services, which are applied on some of the most important clinical trials in neuroscience, providing valuable insights to disease progression and patient safety, enabling our clients to make better informed decisions earlier in the clinical development pathway.
And our people make all this happen. We have a passionate, dedicated team, bringing together the essential skills needed to innovate and develop cutting-edge technologies, provide the support our customers need and enhance our service offering.
As our team continues to grow we are now looking to hire a Quality Assurance Coordinator.
Purpose of the role:
The Quality Assurance Coordinator (QAC) will report to and support the leading Quality function (SVP Quality, Compliance and Regulatory Affairs) in ensuring IXICO’s Quality Systems and Quality Culture are of a sufficient standard to enable regulatory compliance and to enhance business effectiveness.
Support the enhancement of IXICO’s Quality Culture.
- Lead in enhancing IXICO’s Quality Culture and values; embedding this by carrying out duties requested by the Quality Lead. This includes:
- Acting as a ‘Quality Ambassador’ internally and externally for IXICO
- Proactively communicating the IXICO Quality Policy to ensure that the Quality Policy is understood by all staff.
- Promoting, leading and participating in continual improvement activities/projects
- Assisting in the identification and management of risks and supporting the delivery of effective Preventive Actions.
- Initiate Deviation Reports (nonconformities), perform/assist with deviation investigations, and manage deviations to ensure Corrections, Corrective Actions and Preventive Actions are appropriately documented, effective and timely. Provide input and KPIs/metrics to the CAPA Review Board. Deliver staff training in the Deviation and CA/PA process.
- Act as subject matter expert (SME) for Good Clinical Practice (GCP) ensuring that the IXICO Management System (IMS) continually meets all applicable GCP requirements. Develop and deliver Quality System/GCP new-starter and refresher staff training.
- Continual improvement – lead and facilitate continual improvement projects across the business to further improve the IMS, operational efficiencies and client satisfaction.
- Support the change management process, providing guidance to staff and review/approval of change from a Quality perspective.
- Prepare and provide KPIs/metrics in order to develop, maintain and improve the integrated IXICO Management System; prepare and present quality KPIs/metrics at IXICO Management Review meetings, Townhalls (all employee) and other departmental meetings.
- Support IXICOs preparations for Client Audits and Regulatory Agency Inspections as requested by the SVP Quality & Compliance.
- Conduct Internal Audits as required in order to ensure compliance with statutory, regulatory and IXICO management system requirements.
- Conduct supplier (vendor) and subcontractor Assessments/Audits as required in order to evaluate, select and monitor IXICO suppliers and subcontractors.
- Set up and administer IXICO’s electronic Management System (TrackWise Digital) and provide training and support to staff in the sub-system elements i.e. document management system (DMS), training management system (TMS), Quality Event and CAPA management, Change Management, Feedback/Complaints and Audits.
- Administer and monitor the DMS and coordinate the periodic reviews of IMS documents with applicable areas as per schedule, ensuring any updates happen by the cycle review date.
- Administer and monitor the TMS to ensure that staff training is documented and occurs as per schedule; prepare and present training system performance KPIs/metrics.
- Participate in identification and recording of risks as per the Risk Management process; Support the identification and implementation of Improvement and Preventive Actions in order to treat and minimise risks; develop and deliver Risk Management staff training.
- Support all members of the Quality & Compliance department in the delivery of departmental and company objectives.
- Previous experience as a quality professional in either the Biopharma, Medical Devices/Diagnostics and/or clinical research industries;
- Experience of maintaining and continually improving Quality Management Systems;
- Good understanding of Good Clinical Practice (GCP) and associated clinical trials regulations;
- Knowledge and experience of performing internal Quality/Management System Audits and external Supplier/subcontractor quality audits.
- Experience of co-ordinating external (client) audits and regulatory inspections
- Excellent MS Office package experience
- Ability to collate, classify and perform simple statistical analysis on information/data
- Good written and verbal communication skills
- Multi-tasker, organised and able to manage time efficiently
- Detail and task oriented, with a strong focus on quality
- Previous experience in a professional working environment
- Bachelor degree or equivalent.
- Experience of Clinical Trials and Imaging (MRI/PET) would be beneficial.
- Lead Internal Auditor training and experience of performing GCP, ISO 13485, or ISO9001, ISO 27001 audits
- Knowledge of Information Security/Information Privacy/GDPR requirements and systems
- Knowledge of the Sparta Systems electronic TrackWise Digital system
- Generous employer pension contribution of 6%
- 25 days annual leave, increasing up to 28 days with every year at IXICO
- Various discounts in retail, food & drink and entertainment through our benefit portal
- Annual salary review and company bonus scheme
- Life Assurance scheme
- A very sociable, supportive and highly motivated team
- A modern working environment and excellent location in the heart of the City of London
- A company in an industry where your work has an impact every single day
How to Apply
IXICO is working hard to create a representative, inclusive and super-friendly team, because we believe different experiences, perspectives and backgrounds make a better workplace, and ultimately better services.
IXICO doesn’t discriminate on the basis of race, colour, religion or belief, gender, national origin, age, sexual orientation, marital status, disability or any other protected class.
This is a great opportunity for a Quality professional to thrive in an engaging and fast-paced environment, to make a difference on an every day basis. You will be given support to enable you to grow with your challenges, and we pride ourselves to be a sociable and diverse bunch of people, who are all working together on one big mission: Improving brain health. Will you join us?
If you think IXICO should meet you, please send us your CV and covering letter by email to email@example.com. We are looking forward to your application!