Day-Shift Quality Assurance Lead — Shop Floor Excellence

Bristol Myers Squibb; Harvard (MA); On-site; USD 130,000 - 158,000; Full time

Benefits offered by this job

Wellbeing support

Retirement benefits

Insurance offerings

Flexible work models

Job summary

Bristol Myers Squibb is seeking a Senior QA Leader to oversee day-shift operations, mentoring four day-shift managers and teams while upholding cGMP standards. You will drive continuous improvement and cross-functional collaboration to ensure patient safety.

The role reports to the Associate Director of Quality Assurance Shop Floor and belongs to the QASF Leadership Team. Expect strategic problem solving, leadership in audits, and strong cross-functional influence across Manufacturing, Quality

Qualifications

• 8+ years of relevant cGMP experience, preferably with manufacturing site exposure.
• Experience in FDA/EMA regulations in biopharma or cell therapy manufacturing.
• Master’s degree in STEM or MBA preferred; undergrad with equivalent experience acceptable.
• Leadership of on-site quality operations and 12-hour shifts.
• Strong written and verbal communication; ability to mentor staff.

Responsibilities

• Lead day-shift QA operations and mentor managers and teams.
• Oversee deviation, CAPA, change control, and batch record processes.
• Collaborate across Manufacturing, Quality Labs, and Supply Chain.
• Ensure patient safety and compliance with cGMPs.
• Prepare and present audits/inspections materials.

Skills

Leadership

Quality systems

cGMP experience

Cross-functional collaboration

Analytical thinking

Problem solving

Education

Master’s degree in STEM or MBA

Bachelor/Associates degree

Tools

MES

SAP

TrackWise

Veeva

LIMS

Job description

Bristol Myers Squibb is seeking a Senior QA Leader to oversee day-shift operations, mentoring four day-shift managers and teams while upholding cGMP standards. You will drive continuous improvement and cross-functional collaboration to ensure patient safety.

The role reports to the Associate Director of Quality Assurance Shop Floor and belongs to the QASF Leadership Team. Expect strategic problem solving, leadership in audits, and strong cross-functional influence across Manufacturing, Quality