QA Operations Leader - Biotech Tech Transfer & Validation

Socket.dev; Harvard (MA); On-site; USD 130,000 - 158,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

401(k) plan

Job summary

Bristol Myers Squibb is seeking a Sr Manager QA Technical Operations in Devens, MA. Lead a team overseeing QA for technology transfer, automation, validation, and site engineering maintenance, while coordinating with cross-functional partners to ensure regulatory readiness and product quality.

The role requires extensive QA leadership, deep knowledge of cGMP, and experience in biopharmaceutical operations with a track record of delivering compliant, scalable processes.

Qualifications

• Bachelor's degree in science, engineering, biochemistry or related discipline; 8+ years biopharmaceutical ops with 2+ years management preferred.
• Experience building high-performance teams and strong QA/compliance in commercial biologics manufacturing.
• Knowledge of US/EU cGMP regulations and regulatory authority experience.

Responsibilities

• Provide leadership to a team of Quality managers overseeing QC projects and daily activities.
• Oversee Cell Banking, Change Controls, QA for Technology Transfer, Automation, Validation, and MS&T programs.
• Collaborate with stakeholders across OE, MT, MST, PD, CMC, QPL for tech transfer and risk management.
• Represent quality in project and governance meetings and audits.

Skills

Leadership

Regulatory knowledge

Quality assurance

Communication

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

SAP

LIMS

Maximo

Syncade

DeltaV

Veeva Vault

Job description

Bristol Myers Squibb is seeking a Sr Manager QA Technical Operations in Devens, MA. Lead a team overseeing QA for technology transfer, automation, validation, and site engineering maintenance, while coordinating with cross-functional partners to ensure regulatory readiness and product quality.

The role requires extensive QA leadership, deep knowledge of cGMP, and experience in biopharmaceutical operations with a track record of delivering compliant, scalable processes.