Senior Quality Systems Analyst
Job Summary
Operating as a senior individual contributor, the full-time Senior Business Systems Analyst - Quality Systems will analyze, design, implement, and continuously improve regulated business systems supporting Quality operations in a remote biopharmaceutical environment.
Key responsibilities
- Lead requirements gathering, process mapping, and gap analysis for Quality Systems
- Ensure systems comply with GxP, 21 CFR Part 11, and data integrity principles
- Act as a subject matter expert during internal and external audits and inspections
Required qualifications
- Bachelor's degree in Information Systems, Engineering, Life Sciences, or related discipline
- 6-10 years of experience in business systems analysis, with at least 4-6 years supporting GxP-regulated Quality Systems
- Proven experience with eQMS platforms such as Veeva Vault QMS or TrackWise
- Strong background in system validation and regulated Software Development Lifecycle methodologies
- Deep understanding of biopharmaceutical Quality processes and regulatory expectations
Complete Job Description
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