Senior QA Leader: Tech Transfer & Validation Ops

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

Benefits offered by this job

Health Coverage

Wellbeing Programs

Financial protection (401k)

Job summary

Bristol Myers Squibb seeks a Sr Manager QA Technical Operations to lead a team of quality managers overseeing QC projects, change controls, and tech transfer activities at the Devens, MA site. You will drive audits, risk management, and cross-functional collaboration to ensure compliant manufacturing operations.

You will mentor staff, coordinate inspections readiness, and partner with stakeholders across QA, manufacturing, and regulatory functions to support continuous improvement and site

Qualifications

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required
• A minimum of 8 years’ experience in biopharmaceutical operations with 2 years of prior management experience desirable
• Experience in building and growing an organization into a high-performance team.
• Strong background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing.
• Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Demonstrated leadership, interpersonal, communication, and motivation skills.

Responsibilities

• Provides direct supervision of personnel approving change controls, protocols/reports and investigations in support validation and automation teams.
• Provides direct supervision of personnel reviewing manufacturing maintenance, calibration and scheduling programs for preventive maintenance and calibrations.
• Interfaces in clinical and commercial tech transfer meetings, including with stakeholders from OE, MT, MST, PD, CMC, QPL and relevant organizations supporting transfer to manufacturing areas.
• Accountable to tracking and managing risks and decisions coming out of technical transfer sub-teams and coordinating resolution with Quality Tech Transfer Lead and QA AD.
• Makes decisions and communicates on minor tech transfer decisions and risks. Keeps track of tech transfer milestones for resource allocation.

Skills

Leadership

Quality Assurance

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in science/engineering/related

8+ years biopharmaceutical operations experience

Tools

SAP

LIMS

Maximo

Syncade

DeltaV

Veeva Vault

Job description

Bristol Myers Squibb seeks a Sr Manager QA Technical Operations to lead a team of quality managers overseeing QC projects, change controls, and tech transfer activities at the Devens, MA site. You will drive audits, risk management, and cross-functional collaboration to ensure compliant manufacturing operations.

You will mentor staff, coordinate inspections readiness, and partner with stakeholders across QA, manufacturing, and regulatory functions to support continuous improvement and site