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 Quality Assurance Manager (QAM) 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 and embedding this by carrying out duties requested by the QAM.
- The QAC will co-ordinate process and training reviews to enhance business effectiveness.
- Oversight and co-ordination of Quality Plans for the different functional areas in IXICO.
- Identify those areas of quality processes that need to be improved and propose new ways to improve quality at IXICO.
- Act as a Quality Ambassador internally and externally for IXICO.
Internal reporting & Management Review
- The QAC will collate and provide metrics/KPI’s to assist the QAM and all departments to monitor Quality Plans/Quality Objectives and performance.
- The QAC shall collate, review and compare information/documentation to input into the Management Review process and other business reviews to improve quality and consistency.
Deviation and CAPA management
- To develop, maintain and improve the IXICO Quality Assurance System to ensure Investigations, Corrections and CAPAs are tracked and closed effectively and on time.
- To assess potential observational CAPAs and ensure that all deviations are logged and tracked so the Quality function can evaluate and document the agreed resolution.
- To provide oversight and metrics for all RT Queues, as required.
- To assist with Quality Investigations as required as requested by the QAM.
Internal & External Audit
- Assist and conduct Internal/Supplier Audits as required
- Administer the Internal & Supplier audit plan and records.
- Supporting preparations and administration of Client Audits and Regulatory Agency Inspections as required.
- Act as a scribe during Inspections and Client Audits.
- Ensuring IXICO’s electronic Document Management System (DMS) and Training Management System (TMS) are maintained and procedural updates occur by the periodic review date.
- Taking inputs from other functions, prepare draft IXICO Management System documents and coordinate the appropriate approvals.
- Review draft procedures against regulatory requirements and to ensure these are streamlined where possible.
Training Compliance and Delivery
- Ensuring IXICO’s training is documented and completed in good time.
- To ensure training records are available for audits and inspections.
- Provide GCP and ISO QMS expertise, guidance and training as required.
- Provide training for staff.
- Maintain awareness and understanding of applicable policies and procedures as defined in the employee training plan: including but not limited to IXICO’s Quality Policy, Information Security Policy, Personal Information Management System Policy; ensure awareness of responsibilities under IXICO’s policies and procedures.
- Experience as a quality professional (2-5 years) in the pharmaceutical/medical device/CRO regulatory environment or running clinical trials in a University or hospital setting.
- Bachelor degree or equivalent work experience.
- Strong proficiency in Microsoft Office applications (MS Excel and PowerPoint in particular).
- Experience of maintaining and enhancing Quality Management Systems.
- Good written and verbal communication skills.
- Good organisational skills and the ability to multi-task with a goal-oriented approach whilst maintaining attention to detail;
- Excellent understanding of ISO Quality Management Systems.
- Experience of co-ordinating audits and regulatory inspections.
- Experience of Clinical Imaging.
- Experience of GCP and associated clinical trials regulations.
- Knowledge of ISO27001 Information Security & Privacy / GDPR requirements.
- Represent the company effectively when dealing with customers, external third-party auditors and consultants;
- Strong ability to work in a small company environment and build good working relationships with all levels of the business;
- An excellent communicator able to influence others to bring about quality improvements.
- 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 firstname.lastname@example.org. We are looking forward to your application!