Role Purpose
IT Quality & Compliance is responsible for governing and sustaining IT Quality and Computer System Validation (CSV) compliance for enterprise‑wide digital systems supporting regulated (GxP) processes. The role ensures that Enterprise systems such as SAP HANA, are validated, compliant, inspection‑ready, and maintained in a continuous state of control in alignment with GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity principles, and internal IT Quality SOPs.
Key Responsibilities
IT Quality & CSV Governance
- Provide leadership and oversight for IT Quality and CSV activities across enterprise systems.
- Provide IT Quality and CSV oversight & quality guidance for Enterprise systems preferably on SAP HANA, Source‑to‑Pay, Contract Management Systems, and associated integrations.
- Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity, and internal QMS procedures.
- Review and approve validation plans, risk assessments, IQ/OQ/PQ protocols and reports, traceability matrices, and validation summary reports.
- Provide compliance recommendations for system release, go‑live, and decommissioning.
- Ensure execution and review of periodic reviews, including user access review, audit trail review, backup/restore, and disaster recovery testing.
- Lead and support internal audits, vendor audits, and regulatory inspections from an IT Quality perspective.
- Communicate compliance status, risks, and validation strategies to senior leadership and stakeholders.
- Work closely with Process Owner, System Owner, Technical SMEs, QA & Vendors
- Act as the single point of contact for CSV‑related matters during project and BAU activities.
Qualification Requirements
Bachelor's or master's degree in engineering, Computer Science, or related discipline.
Experience Requirements
8–12+ years of experience in IT Quality, CSV/CSA, or regulated IT environments, with hands‑on exposure to enterprise systems preferably on SAP HANA, Source‑to‑Pay platforms, and Contract Management Systems.
Skills Requirements
- SDLC, Computer System Validation (CSV) / Computer Software Assurance (CSA) of Enterprise systems (including Cloud based IT systems).
- IT Process & Controls (ITIL, Data Security, Infrastructure controls)
- Regulatory Interpretation - (GAMP 5, 21 CFR Part 11, EU Annex 11, ISO, NIST)
- Leadership and stakeholder communication
