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Head of Validation

2020-09-03 18:52:332020-09-30 Pop Science
Job Type Permanent Full Time
Location London
Area Central London London
Sector Technology and IT
Salary £55k - 75k per year + benefits
Start Date ASAP
Job Ref 918
Job Views 348
Description

Are you a Software and Computer System Validation Leader 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 ideally have 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. They are innovating in both science and technology, so this is a very interesting area to be in and you will make a difference to patient's lives. 

The Head of Validation 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 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:

  • Act as document owner for all validaiton documents for all aspects of the software development life cycle, including verification and validation 
  • 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, ensuring linkage to the 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  software development, testing & validation.
  • Work with  Science, Technology & Development teams to identify tools (e.g. Jira) and methodologies to enable robust and efficient software development and testing, including automation.
  • Work with Agile Scrum teams and  meetings as required
  • 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.

Essential

  • 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 and 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.
  • Multi-tasker, organised and able to manage time efficiently
  • Detail and task oriented, expert in quality

Desirable

  • 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)
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