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 Head of Quality.
Purpose of the role:
Responsible for providing GCP and regulatory expertise to IXICO via definition and management of the Quality Management System (QMS) and Quality Assurance System, ensuring IXICO is fully prepared for client audits and regulatory inspections.
Responsible for management of the company's quality standards, systems and processes to ensure an environment that is compliant with the requirements of ICH-GCP and clinical trials regulation along with the company's ISO accreditations. Ensuring that the Company's Policies and Procedures are fit for purpose, that systems are in place to respond to CAPA’s in a timely manner.
Essential Duties and Responsibilities:
- Take ownership, develop and maintain and continually improve business processes and procedures.
- To ensure quality compliance against Good Clinical Practice (GCP), clinical trials regulations and MDD/MDR expectations; e.g., EU Directives/Regulations, CFR 21 Parts 11 and 312, along with guidelines and other applicable external legislation and standards e.g., ISO 13485, ISO 14971, MDR 2017/745, ISO 27001, and Data Protection legislation (e.g. GDPR).
- Provide GCP, MDR, Computer System Validation (CSV) and regulatory expertise, guidance and training for the company.
- Implementation and maintenance of all aspects of the Quality System and SOP life cycle including (but not limited to) process development, review, implementation, training, monitoring of process compliance e.g., via evaluation of SOP deviations, revision and decommissioning of SOPs.
- Updating, maintaining and improving the Quality Manual and process content on our document management system (transition from home-built system to TrackWise Digital).
Implementation and maintenance of the QA and Compliance Strategy including (but not limited to);
- Defining, maintaining and periodically reviewing the strategy for effectiveness.
- Take ownership of the internal and key suppliers auditing schedule and process.
- Host and manage audits by potential and on-going customers and regulatory inspections (including but not limited to MHRA and FDA).
- Manage the internal audit programme and perform required audits.
- Support implementation and oversight of Corrective Actions and / or Preventive Actions and other issues that may impact quality & compliance.
- Identify those areas of quality processes that need to be improved and propose new ways to improve quality at IXICO while maintaining those processes and systems that are working.
- Ensuring that the quality system is established, implemented, maintained and monitored in accordance with relevant standards.
- Monthly reporting to senior management of quality and regulatory metrics and issues; e.g., non-conformities and progress in resolving these through monthly reporting.
- Working with Technical, R&D and Operations staff to review, update and approve policies, procedures, work instructions and forms relating to all aspects of the software life cycle; act as the Subject Matter Expert (SME) for Computer System/Software Validation requirements; review and approve for Quality applicable software development & validation documentation.
- Promote the development of a science and risk-based compliance focused culture, ensuring product and service quality is commensurate with IXICO values.
- Develop and administer the Risk Management System (ISO31000 & ISO14971) and coordinate risk reviews and escalations to CFO and ELT
- Acting as the Management Representative for the IXICO Management System, prepare and conduct with top management, reviews of IXICO's QMS at planned intervals to ensure its continued suitability, adequacy and effectiveness.
Knowledge, Skills and Experience Required for the Role:
- Educated to at least degree level in a scientific discipline (e.g. in Computer Science or technical/life science subject).
- Extensive experience as a quality professional in the pharmaceutical/medical device regulatory environment, and has held Quality / Regulatory positions for a minimum of ten years.
- Experience within both large pharmaceutical companies and CROs is desirable.
- Extensive experience of definition and maintenance of Quality Management Systems, audit planning and management and the clinical trials process.
- Excellent understanding of GCP and clinical trials regulation and compliance requirements.
- Experience of ISO Quality Management Systems.
- Knowledge of international Information Security / Privacy requirements (GDPR, ISO27001, HIPPA etc).
- Experience of software validation (e.g. GAMP/Annex 11) gained within a regulated industry i.e. pharmaceutical/medical devices, or other software critical organisation.
- Experience in submissions to regulators and interaction with regulators is desirable.
- Experience of managing external (client) audits and regulatory inspections.
- Ability to work in a small company environment and influence at all levels in the organisation.
- Strong organisational skills and the ability to multi-task with a goal-oriented approach whilst maintaining attention to detail.
- Ability to prioritise and manage tasks/requests for support and sometimes competing demands.
- A strong team-player. Proactive and personable.
- An excellent communicator able to influence others to bring about quality improvements.
- Highly IT literate, methodical and meticulous and results-driven.
- Generous employer pension contribution of 6%
- 25 days annual leave, increasing up to 28 days with every year at IXICO
- Annual salary review and company bonus scheme
- Various discounts in retail, food & drink and entertainment through our benefit portal
- 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
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 highly experienced 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!