Who we are looking for:

A member of Vor Bio's Manufacturing team, the Compliance Specialist will lead investigations, CAPAs and Change Controls related to our internal manufacturing. In addition, this role will help build out the sterility assurance program including aseptic operator qualification and ongoing aseptic process qualifications and support equipment lifecycle management. 

Key areas of responsibility:

• Provide quick, quality-based decisions while serving as the immediate escalation path for all operational staff during cell therapy manufacturing activities
• Facilitate and lead critical site meetings to investigate and coordinate the resolution of manufacturing deviations and investigations, CAPAs, change controls through use of Root Cause Analysis tools and risk assessments.
• Support manufacturing continuous improvement initiatives
• Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics
• Collaborate with appropriate stakeholders to author, review or revise applicable SOPs, batch records, and other operational related documents
• Conduct technical training for manufacturing operations
• Conduct review of aseptic operations to ensure compliance to procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations
•  Other tasks and duties as assigned by Area Management

Qualifications:

• Highly skilled, flexible worker with strong people skills and an extensive background in cGMP manufacturing
• Bachelor’s degree in a related field with a minimum of 5 years of experience working in the pharmaceutical or biotechnology industry
• Knowledge and experience in Current Good Manufacturing Practices (cGMP) regulations, documentation, and compliance
• Experience leading investigations, technical writing, and sterility assurance 
• Minimum of 3 years of cGMP production experience or Quality Assurance
• Direct experience in Cell Therapy manufacturing and associated specialized equipment)
• Excellent communication and organizational skills with an ability to prioritize effectively and work cross-functionally to deliver results within established timelines
• Must be detail oriented, able to work in a fast-paced environment