V
Posted 2 hours ago
Quality Systems Manager
VorQuality Systems Manager
Perks & benefits
Commission
Requirements
Bachelor's degree in Life Sciences or Engineering, 3-5 years GxP quality systems experience, Biotech or pharmaceutical industry experience, Knowledge of FDA, EMA, and ICH regulations
Skills
Quality AssuranceGMPCompliance
About the role
Responsibilities
- Oversee and ensure compliance with GxP for systems including EDMS, LMS, and eQMS
- Manage the creation, review, approval, and storage of GxP documents (SOPs, Work Instructions, Policies)
- Manage the electronic Document Management System (eDMS)
- Oversee the GxP training process and maintain compliance for all stakeholders
- Support regulatory inspections and audit requests (FDA, EMA, etc.)
- Implement and report on quality metrics and KPIs
- Collaborate with cross-functional teams including IT, CMC, Supply Chain, and Clinical Operations
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related field
- 3-5 years of experience in quality systems, QA, or document/training management in biotech or pharma
- Expertise in GxP, regulatory requirements (FDA, EMA, ICH), and industry best practices
- Strong problem-solving, analytical, and communication skills
Preferred Qualifications
- Experience with Phase 3 clinical trials and the transition to commercialization
Benefits
- Comprehensive health coverage
- Flexible paid time off
- Generous parental leave
- Competitive 401(k)
- Education assistance and wellness resources
About the Company
Vor is a biotechnology company focused on tackling autoimmune diseases at their root cause through advanced science and innovative therapies.
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Vor · Boston
