Cell Therapy Quality Assurance Lead — Shop Floor

Bristol Myers Squibb; Harvard (MA); On-site; USD 100,000 - 122,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Stock opportunities

Job summary

Bristol Myers Squibb seeks a Manager, Shop Floor Quality Assurance, Cell Therapy in Devens, MA to lead quality operations on the floor. You will oversee deviations, CAPA, batch record handling, and collaboration with Manufacturing, QC labs, and Supply Chain to ensure cGMP compliance and rapid issue resolution.

High attention to detail, strong leadership, and experience in a sterile environment are essential as you mentor staff and drive continuous improvement in a fast-paced biotech setting.

Qualifications

• Ability to lead on-site quality operations teams.
• Experience with change control, deviations, investigations, and CAPA management.
• Experience in aseptic/sterile environments or microbial controls is preferred.
• Ability to interpret internal policies, regulatory guidelines and quality systems.
• Strong communication and leadership in a fast-paced manufacturing setting.

Responsibilities

• Provide leadership for on-the-floor quality oversight during 6am–6pm shifts.
• Understand Cell Therapy processes for real-time decision-making.
• Lead investigations and coordinate cross-functional teams to resolve issues.
• Approve deviation records within the quality management system.
• Coach and mentor QA staff on the manufacturing floor.
• Oversee QA on-the-floor systems and drive continuous improvement.

Skills

Quality leadership

Quality management systems

Regulatory compliance

Data interpretation

Cross-functional collaboration

Education

Bachelor's degree in STEM

Tools

MES

SAP

LIMS

TrackWise/Veeva

Job description

Bristol Myers Squibb seeks a Manager, Shop Floor Quality Assurance, Cell Therapy in Devens, MA to lead quality operations on the floor. You will oversee deviations, CAPA, batch record handling, and collaboration with Manufacturing, QC labs, and Supply Chain to ensure cGMP compliance and rapid issue resolution.

High attention to detail, strong leadership, and experience in a sterile environment are essential as you mentor staff and drive continuous improvement in a fast-paced biotech setting.