QA Tech Ops Leader for Tech Transfer & Validation

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

Job summary

Bristol Myers Squibb is seeking a Sr Manager QA Technical Operations to lead QA teams overseeing CTQ/transfer activities and site programs in Devens, MA. You will direct QA for technology transfer, automation, validation, and maintenance, while ensuring regulatory readiness and compliance.

The role requires strong leadership, cross-functional collaboration, and deep knowledge of biopharma QA. On-site work at Devens with involvement in audits and continuous improvement.

Qualifications

• Bachelor's degree in science, engineering, or related discipline.
• 8+ years in biopharmaceutical operations with 2+ years in management preferred.
• Experience building high-performance teams.
• Strong QA operations experience and regulatory compliance knowledge.
• Knowledge of biotech bulk and finished product manufacturing and analytical testing desirable.
• Familiarity with US/EU cGMPs and regulatory authority interactions.

Responsibilities

• Provide leadership to a team of Quality managers overseeing QC projects and daily activities.
• Supervise QA for tech transfer, automation, validation, MS&T, and site maintenance programs.
• Lead preparation for and hosting of regulatory and customer audits.
• Interface in technical transfer governance meetings with multiple stakeholders.
• Track tech transfer milestones and coordinate resource allocation and risk assessments.

Skills

Leadership

Quality assurance

Regulatory knowledge

Biopharma operations

Cross-functional communication

Education

Bachelor's degree in science or engineering

Tools

SAP

LIMS

Maximo

Syncade

DeltaV

Veeva Vault

Job description

Bristol Myers Squibb is seeking a Sr Manager QA Technical Operations to lead QA teams overseeing CTQ/transfer activities and site programs in Devens, MA. You will direct QA for technology transfer, automation, validation, and maintenance, while ensuring regulatory readiness and compliance.

The role requires strong leadership, cross-functional collaboration, and deep knowledge of biopharma QA. On-site work at Devens with involvement in audits and continuous improvement.