Are you a Software Validation Lead looking for a new challenge in a rapidly growing clinical research organisation focussed on medical imaging, with a strong focus on technology and digital health? You will need a proven background in clinical trials to be able to be considered for this role. 

Our client have lead digital health technologies for serious diseases of the brain.  They work across all phases of clinical research and provide expert digital solutions  to complex medical problems. 

The Software Quality & Validation Lead supports the compliant and timely design/development, testing, verification, validation, configuration and life cycle management of software developed. 

This role owns the drafting, review & approval of software development and validation policies and procedures, ensuring best practice for ‘security & privacy by design’ principles. 

As this is working with clinical trials data, you must have experience 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 include:

• Act as document owner to draft, review and maintain policies, procedures, work instructions and forms relating the software development life cycle, including verification and validation (V&V).
• Act as the Subject Matter Expert (SME) for software verification and validation requirements, providing associated guidance and training to applicable 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.
• 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
• Maintain awareness of current and proposed best-practice regarding software design, development, testing & validation 
• 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 Management System.
• Evaluate and with QA approve applicable software/technology suppliers.

Knowledge, Skills and Experience Required for the Role:

Essential

• Educated to at least degree level (B.Sc. in Computer Science, Mathematics or technical/life science subject) 
• Experience of software development & validation (e.g. GAMP/Annex 11) from CRO, pharmaceutical, biotech , medical devices, life science technology 
• 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

Desirable

• 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).

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