Technical Product Lead
- Location
- Folkestone, England, United Kingdom
hypercare. Contribute to Computer System Validation (CSV): URS/FS inputs, risk assessments, test scripts, evidence and approvals. Ensure change follows SDLC/Agile, GxP, security, data privacy, and change control expectations. What we're looking for (essential) Hands-on experience with Veeva Vault RegulatoryOne (RIM). Strong background … regulated environments. Knowledge of PLM, QMS, and Regulatory processes (change control, deviations, CAPA, audits, complaints, submissions/registrations, regulatory documentation). Working understanding of GxP, 21 CFR Part 11, EU Annex 11, data integrity and audit trails. Confident working with global stakeholders and vendors; able to influence and drive alignment. ...