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.
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:
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.