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Accountabilities:
- Implement and maintain a comprehensive Quality Management System aligned with regulatory expectations.
- Manage eQMS including document control, CAPA, audit processes, and risk management.
- Provide quality oversight for clinical trials and software development, ensuring GCP and SDLC compliance.
Requirements:
- Bachelor's degree and 8+ years of progressive quality management experience in regulated industries.
- Strong knowledge of GCP, ISO 9001, 21 CFR Part 11, and related life sciences compliance.
- Hands-on experience with eQMS administration, clinical trial quality, and audit management.
Benefits:
- Competitive annual salary of $134,985 – $163,247, plus equity and performance-based bonus.
- Comprehensive medical, dental, and vision coverage, and 401(k) retirement plan.
- Flexible remote work environment with paid time off and professional development opportunities.
Partner Company
The partner company is a fast-growing healthcare and life sciences organization focused on improving clinical research. It values collaboration, curiosity, and continuous improvement, and supports teams through scalable systems and risk management.