Responsible for administering, maintaining, and continuously improving Apnimed's electronic Quality Management System (eQMS) and associated quality processes, ensuring inspection readiness and supporting regulatory compliance.
The expected annual base salary range for this role is $170,000.00 to $190,000.00.
- Serve as subject matter expert and administrator for the electronic Quality Management System (eQMS), evaluating proposed system changes and coordinating testing, validation, and deployment activities.
- Support the integration of new business processes, departments, and vendors into the Quality Management System, and oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
- Maintain system documentation, including procedures, work instructions, validation documentation, and configuration records.
- Administer the training program: confirm assignments and curricula reflect quality system responsibilities, manage role-based eQMS training and user support, and maintain a centralized library of user guidance, job aids, and FAQs.
- Provide oversight and support for core quality processes, including document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
- Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
- Nice to have: Direct administrator experience with Veeva Quality
- Nice to have: Experience with computerized system validation (CSV) and 21 CFR Part 11 compliance
- Nice to have: Experience supporting both development-stage and commercial pharmaceutical operations
- Nice to have: Implementing or enhancing eQMS platforms
- 401(k) with company match
- Generous time off for vacation
- Generous healthcare benefits
- Flexible working environment
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