Sr. CSV Analyst

Role: Senior CSV Analyst supporting validation and compliance of GxP computerized systems within a biopharma environment, preparing for regulatory inspections such as FDA PAI and EMA reviews. Responsibilities include conducting gap assessments, maintaining validation documentation, leading validation activities for cloud-based and SaaS applications (e.g., Veeva Vault, Medidata), ensuring data integrity in line with ALCOA+ principles, and supporting supplier and CRO qualification audits. The role also involves collaboration with IT and Finance on SOX controls, contributing to validation strategy evolution toward CSA methodology, and updating SOPs and work instructions. Requirements: Bachelor's in life sciences, engineering, or related field; minimum 6 years of FDA-regulated validation experience, with direct inspection support, especially in cloud/SaaS platforms. Expertise in 21 CFR Parts 11, 210/211, 312/314, EU GMP Annex 11, GAMP 5, and data integrity guidance is essential. Preferred skills include experience with Veeva Vault, Medidata, CSA approach, and electronic validation tools (Kneat, ValGenesis). Certification such as ASQ CQA is a plus. The position is remote with occasional travel for site visits and inspections. High-value details: focus on validation of clinical and manufacturing systems, supporting company transition from clinical to commercial phases, and a senior-level expectation with a strong compliance and documentation skill set.