Quality Systems Manager
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Responsibilities
- GxP Training Management: Oversee the training process to maintain compliant training for GxP stakeholders. Support the establishment of training curricula and training materials. Track completion rate of training of stakeholders. Responsible for the ongoing management of the training system.
- Non-GxP System Support: Serve as the Corporate Training Coordinator and support day-to-day Corporate Document Management and Training activities, including ensuring corporate documents are maintained in the appropriate system and assigned correctly to support broader business needs.
Requirements
- Education :
- Bachelor's degree in Life Sciences, Engineering, or a related field.
- Minimum 3-5 years of experience in quality systems, quality assurance, document management/training management within the biotechnology or pharmaceutical industry.
- Experience with Phase 3 clinical trials and the transition to commercialization is highly preferred.
- Skills & Competencies :
- Expertise in GxP, regulatory requirements, and industry best practices (FDA, EMA, ICH).
- Ability to collaborate with cross-functional teams and complex initiatives.
- Excellent knowledge of quality systems, documentation, and compliance management.
- Exceptional problem-solving, troubleshooting, and analytical skills.
- Strong communication and presentation skills, both written and verbal.
- Ability to work effectively with communication and office tools in a remo
Benefits
Additional Information
J oin Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you're not just working on a medicine. You're part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication - a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren's syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. POSITION: Quality Systems Manager The Quality Systems Manager will be responsible for overseeing and ensuring compliance with current Good Practices (GxP) for applicable GxP systems, including document management (EDMS), training (LMS) and the electronic quality management system (eQMS). This role will coordinate and execute document management activities in an effective and compliant manner. This role will also provide training and maintain training compliance of all applicable stakeholders that impact clinical and commercialization activities. Additionally, this role will collaborate with internal and external teams, ensuring alignment of quality standards and the timely execution of all deliverables. The individual will possess a strong hands-on expertise in GxP quality systems and operations within the biotech industry.
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