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 used by the global Pharmaceutical industry to select patients for clinical trials, assess the safety and efficacy of new drugs in development. Our neurological disease focus includes Alzheimer's disease, Huntington's disease, Multiple Sclerosis and Parkinson's.
As the pharmaceutical industry looks to pave the way for personalised medicines, they will need to mine clinical trial and real-world data to tailor specific products to the individual patient. IXICO is uniquely positioned to deliver these approaches by further innovating, customising and scaling our integrated digital platform.
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.
Purpose of the role
The holder of this post will be working closely with all departments at IXICO to provide GCP and regulatory expertise as well as to ensure that IXICO is fully prepared for client audits and regulatory inspections.
They will be responsible for management of the company's quality standards, systems and processes to ensure compliance with the requirements of ICH-GCP and clinical trials regulation along with the company's ISO accreditations. An essential part of this role is ensuring that IXICO's policies and procedures are fit for purpose and that the according systems are in place to respond to CAPA’s in a timely manner.
Essential Duties and Responsibilities:
- Taking ownership of the Quality aspects of our business processes and procedures.
- Ensuring 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.
- Providing GCP, MDR 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.
- Taking ownership of the internal and key suppliers auditing schedule and process.
- Hosting audits by clients and regulatory inspections (including MHRA and FDA).
- Managing and performing the internal audit programme.
- Supporting implementation and oversight of Corrective Actions and/or Preventive Actions and other issues that may impact quality & compliance.
- Identifying measures for improvement of quality processes and work with the departments to action on these.
- 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.
- Promoting the development of a risk-based compliance focused culture.
- Developing and administering the Risk Management System (ISO31000 & ISO14971) and coordinate risk reviews and escalations to senior management.
- Preparing and conducting regular reviews of IXICO's QMS ato ensure its continued suitability, adequacy and effectiveness.
Knowledge, Skills and Experience Required for the Role:
- Bachelor or Master degree in a scientific discipline
- Minimum of 5-8 years of experience as a quality professional in a Quality position in the pharmaceutical regulatory environment
- Extensive experience in the maintenance of Quality Management Systems, audit planning and management
- Excellent understanding of GCP regulation and compliance requirements.
- Experience in ISO Quality Management Systems.
- Knowledge of international Information Security / Privacy requirements (GDPR, ISO27001, HIPPA etc).
- Experience in managing internal and external audits
- Experience within both large pharmaceutical companies and CROs is desirable.
- Experience in submissions to regulators and interaction with regulators is desirable.
- Strong organisational skills and great attention for detail
- Ability to prioritise effectively
- Strong team-player, who is acting in a professional and personable manner
- Excellent communication skills across all levels of the business
- Highly IT literate, methodical, meticulous and a complete finisher
- Highly motivated and driven to improve and develop processes
- Generous employer pension contribution
- 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
- A supportive and highly motivated team
- A modern working environment and excellent location in the heart of the City of London
- A company environment 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 & Compliance 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 want to become IXICO's QA Manager please send us your CV and covering letter by email to email@example.com. We are looking forward to your application!