Senior Specialist/Manager, CMC Quality Assurance

Who we are looking for:

Vor Bio is seeking a Senior Specialist/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 the Quality Control (QC) laboratory, 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 reviewing and approving clinical manufacturing batch records, testing records, deviations, and other batch related records and performing disposition activities

• Responsible for quality assurance oversight of testing and environmental monitoring activities

• Responsible for reviewing and approving stability related activities

• Review and approve shipping related activities as well as temperature excursions activities

• Provide on-the-floor QA support for manufacturing activities as needed

• Ensure documentation aligns with regulatory standards and Vor expectations

• Review and approve SOPs and specifications as needed

• Draft, review, approve quality assurance SOPs as needed

Qualifications:

• BA/BS and a minimum of 6-10 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 Quality Management Systems

• 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 preferred

• Experience with QC analytical methods is preferred

• 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