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Job Reference: SC/HQ1152

Software Quality and Validation Lead

  • London, Greater London, England
  • Permanent / Full Time
  • Life Sciences Team
  • £70000 - £90000

Can also be contract

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 us.
  • 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 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 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 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 the software development, testing & validation.
  • Work with our 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 Management System.
  • Evaluate and with QA approve applicable software/technology suppliers.

Qualifications and skills:

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/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

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

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