This is IXICO
One business, one mission: Improving brain health through the application of digital technologies.
Established in 2004, IXICO has established itself as a trusted partner to the global biopharma industry. 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 an Software Validation Lead
> Interim reporting to IT Director. Purpose of the Role:
The Software Quality & Validation Lead supports the compliant and timely design/development, testing, verification, validation, configuration and life cycle management of software developed, purchased and/or utilised by IXICO. This role owns the drafting, review & approval of software development and validation policies and procedures, ensuring best practice for 'security & privacy by design' principles and in compliance with current GCP, 21 CFR Part 11, EU Annex 11, GAMP, FDA QSR Part 820, ISO13485 and ISO27001 regulatory & quality management system requirements. Responsibilities:
Knowledge, Skills and Experience RequiredEssential
- Act as document owner to draft, review and maintain policies, procedures, work instructions and forms relating to all aspects of the software development life cycle, including verification and validation (V&V). Work with all stakeholders including Quality Assurance (QA) to ensure the timely review and approval of such procedural documents.
- Act as the Subject Matter Expert (SME) for software verification and validation requirements, providing associated guidance and training to applicable IXICO staff.
- Review and approve applicable software development & validation documentation, such as User Requirement Specifications (User Stories), Technical Specifications, Test Protocols/Scripts, Verification and Validation protocols and reports.
- Participate in development team stand-ups and regular sprint reviews
- Guide software development teams on risk management requirements, review & approve applicable project risk registers.
- Lead in the review, investigation and local approval of validation events/deviations, ensuring linkage to the IXICO Deviation & Corrective Action system where required.
- Prepare and present software development & validation documentation during client and regulatory agency audits.
- Maintain awareness of current and proposed best-practice regarding software design, development, testing & validation - including security and privacy by design principles.
- Ensure personal information privacy and security compliance best practice are integrated into IXICO's software development, testing & validation.
- Work with IXICO's Science, Technology & Development teams to identify tools (e.g. Jira) and methodologies to enable robust and efficient software development and testing, including automation.
- Attend design review, software development and scrum meetings as required, giving software validation support and direction to team.
- Maintain the software validation library, ensuring all validated systems are listed.
- Work with the IT function to ensure that network & IT infrastructure meets regulatory requirements in terms of design and installation qualification.
- Prepare and report KPIs/metrics regarding the software development and validation process in order to help maintain the effectiveness and improve the integrated IXICO Management System.
- Evaluate and with QA approve applicable software/technology suppliers.
- Educated to at least degree level (B.Sc. in Computer Science, Mathematics or technical/life science subject) or, alternatively, an exceptional candidate.
- Experience of software development & validation (e.g. GAMP/Annex 11) gained within a regulated industry i.e. pharmaceutical/medical devices, or other software critical organisation.
- Experience of contemporary software development and testing practices e.g. Agile.
- Recognised software validation training/certification.
- Strong analytical skills, including the ability to understand and reason about complex information, including statistical principles.
- 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 multi-functional working environment.
- Knowledge of Cloud based systems.
- Knowledge of information system security and privacy/GDPR/HIPPA requirements.
- Knowledge of Artificial Intelligence & Machine Learning systems.
- Knowledge of GCP, ISO13485, ISO27001.
- Knowledge of 'Software as a Medical Device' (SaMD) regulatory requirements/guidance.
- Internal Auditor trained and experience of performing such audits.
- Experience of Clinical Trials and Medical Imaging (e.g. MRI).
How to Apply
- Competitive Salary and various other benefits
- A very sociable, supportive and highly motivated team
- A company in an industry where your work has an impact every single day
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 dedicated neuroscience or radiology professional to thrive in an engaging and fast-paced environment. 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?