Manager, CMC Quality Assurance

Who we are looking for:

Vor Bio is seeking a Manager, CMC Quality Assurance who will be responsible for providing Quality support for CMC Operations at Vor’s internal manufacturing facility and external manufacturing partners. The successful candidate will engage with and support Process Development and Analytical Development, review production data including batch records, QC reports, manage deviations and other quality system records, and perform batch release and disposition. These responsibilities include assisting in and driving risk management activities, and reviewing and approving CMC SOPs, as necessary.

Key areas of responsibility:

• Responsible for clinical batch review, and quality oversight of CMC operations. Review batch data, including batch records, deviations, QC Analytical release testing, and other quality systems as applicable to determine acceptability of product disposition
• Responsible for review and assisting in development of MBRs as needed
• Perform batch release and disposition of Vor investigational products
• Support of Process Development and Analytical Development studies and reports
• Ensure documentation aligns with regulatory standards and Vor expectations
• Review and approval of product and materials stability
• Review drug product temperature excursions for Clinical Trial Material
• Review and approve SOPs and specifications as needed
• Provide on-the-floor QA support for manufacturing activities
• Perform technical review of QC analytical testing (including raw test data) to ensure compliance with established protocols and governing procedures 
• Draft quality assurance SOPs 

Skills and requirements: 

• BA/BS and a minimum of 8-10 years' experience in a Quality Assurance position within a GMP environment.
• Strong knowledge of GMP regulations and quality systems
• Ability to support a risk-based approach to QMS with knowledge of and experience with Quality Risk Management principles.
• Must be able to work collaboratively with cross-functional groups to ensure compliance and adherence to regulations and established procedures.
• Should be highly motivated, flexible, and have excellent organizational and communication skills.
• Experience with cell and gene therapy products is a plus
• Must be able to work both independently and as part of a multi-disciplinary team
• Must be able to work onsite at our Cambridge facility on a regular basis
• Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines 
• Experience in managing relationships with internal departments and external vendors in a collaborative, constructive manner