Senior QA Operations Leader – Tech Transfer & Validation

Bristol-Myers Squibb; Massachusetts; On-site; USD 130,000 - 158,000; Full time

Benefits offered by this job

Health insurance

Wellbeing programs

401(k) plan

Paid time off

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Sr Manager QA Technical Operations to lead a team overseeing quality control projects, tech transfer, validation, and manufacturing support. The role requires directing change controls, site engineering maintenance programs, and regulatory inspections to ensure compliant operations.

You will partner with cross-functional teams, drive risk assessment, workforce development, and contribute to audits and regulatory readiness, while mentoring staff and

Qualifications

• B.S. in science or engineering or related discipline.
• 8+ years in biopharmaceutical operations with 2+ years in management.
• Experience building high-performance teams and QA/compliance in biologics.
• Knowledge of biotech bulk/finished product manufacturing and testing.
• Familiarity with US/EU cGMPs and regulatory authorities.

Responsibilities

• Provide leadership to quality managers for QC projects and daily activities.
• Oversee cell banking, change controls, QA for tech transfer, automation, and validation.
• Support audits and regulatory inspections, and coordinate with cross-functional teams.
• Develop training curricula and manage staff to meet department goals.

Skills

Leadership

Quality assurance

Regulatory compliance

cGMP knowledge

Biopharma manufacturing

Cross-functional collaboration

Risk management

Documentation control

Change control oversight

Leadership development

Education

Bachelor's degree in science or engineering

Tools

SAP

LIMS

Maximo

Syncade

DeltaV

Veeva Vault

Job description

Bristol Myers Squibb in Devens, MA is seeking a Sr Manager QA Technical Operations to lead a team overseeing quality control projects, tech transfer, validation, and manufacturing support. The role requires directing change controls, site engineering maintenance programs, and regulatory inspections to ensure compliant operations.

You will partner with cross-functional teams, drive risk assessment, workforce development, and contribute to audits and regulatory readiness, while mentoring staff and