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csv iq/oq/pq veeva vault quality 21 cfr part 11 gamp 5📋 Description
- Lead IT partnership for Apogee's Quality org; own Veeva Vault Quality.
- Translate QA needs into system changes; manage backlog and release cycles.
- Advise Quality on IT risk and compliant tech use; act as technical advisor.
- Manage CSV activities; author IQ/OQ/PQ docs for GxP systems.
- Drive IT inspection readiness and 21 CFR Part 11 compliance.
🎯 Requirements
- 8+ years IT quality/GxP/CSV in life sciences.
- IT business partner/Quality owner; doc/change/CAPA/training; degree preferred.
- Hands-on Veeva Vault Quality admin; QualityDocs; QMS/RIM a plus.
- IQ/OQ/PQ validation for GxP SaaS/cloud; QA approval authority.
- Knowledge of 21 CFR Part 11, Annex 11, GAMP 5, ICH IT standards.
- Experience with inspection readiness; IT rep during FDA/EMA audits.
🎁 Benefits
- Culture anchored in CORE values: Caring, Original, Resilient and Egoless.
- Fast-paced, dynamic environment; shape culture and wear multiple hats.
- Competitive compensation and benefits package.
- PTO and downtime: three weeks PTO, two shutdowns, paid sick leave.
- Professional growth and development resources.
- Regular all-team in-person meetings to build relationships.
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