Vor Bio

Vor Bio

Quality Systems Manager

Boston, MA

Sponsorship not specifiedDetected 27 days ago
Product ManagementSupply ChainVendor ManagementClinical TrialsFDA RegulatoryCommunicationCollaborationProblem SolvingGxPRegulatory Affairs

About the role

  • When you join Vor, you're not just working on a medicine.
  • Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.
  • Additionally, this role may require QA review of other records and deliverables.

Responsibilities

  • Documentation Management: Perform document control duties to manage the creation, review, approval, revision, obsoletion, and storage of GxP documents (SOPs, Work Instructions, Policies, etc.) and records.
  • Responsible for the ongoing management of the electronic Document Management System (eDMS).
  • GxP Training Management: Oversee the training process to maintain compliant training for GxP stakeholders.
  • Support the establishment of training curricula and training materials.
  • 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.
  • Reporting and Metrics: Support regulatory inspections and audit requests (FDA, EMA, etc.).
  • Support the implementation, maintenance, and reporting of quality metrics and KPIs to ensure alignment with company objectives.
  • Prepare materials for Quality Management Review meetings, including KPI summaries, quality reports, and trending analyses to support management oversight and continuous improvement.
  • GxP Cross-functional Collaboration: Partner with IT, CMC, Supply Chain, Clinical Operations, Clinical QA, Biometrics, Regulatory Affairs, and other GxP teams to implement procedures, training, quality activities, and ensure quality compliance throughout the document and product lifecycle.
  • 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).

Requirements

  • Bachelor's degree in Life Sciences, Engineering, or a related field.
  • We invite you to come as you are.
  • Experience with systems for processing Deviations, Change Controls, Audits, CAPAs, Investigations, Vendor Management, Complaints, etc.
  • Education:
  • Skills & Competencies:
  • Ability to collaborate with cross-functional teams and complex initiatives.
  • The salary range for the Senior Manager Quality Systems is expected to be between $170,000 and $180,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.
  • At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond.

Nice to have

  • 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

  • Expertise in GxP, regulatory requirements, and industry best practices (FDA, EMA, ICH).
  • 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 remote, fast-paced, and evolving environment.

Compensation

  • The salary range for the Senior Manager Quality Systems is expected to be between $170,000 and $180,000 per year.

Company info

  • Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.
  • At Vor, we believe science can do more than manage symptoms.
  • 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.
  • You're part of a mission to redefine the future of autoimmune care.
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