Senior QA Leader - Tech Transfer & Validation Operations

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

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Job summary

Bristol Myers Squibb is seeking a Sr Manager QA Technical Operations in Devens, MA to lead a team overseeing quality control projects, tech transfer, and site operations. You will manage QA for validation, automation and site maintenance programs, and support regulatory audits.

The role requires substantial biopharma QA/tech transfer experience, leadership, and strong knowledge of cGMPs, with a focus on high-quality product delivery and regulatory compliance.

Qualifications

• Bachelor's degree in science, engineering, or related discipline.
• Minimum 8 years' biopharmaceutical operations experience with 2 years in management.
• Experience building and growing a high-performance organization.
• Strong QA operations background and compliance in commercial biologics.
• Knowledge of biotech bulk/finished product manufacturing and analytical testing.
• Knowledge of US/EU cGMP regulations and guidance.
• Knowledge of FDA/EMA or other regulatory authorities.
• Demonstrated leadership, interpersonal and communication skills.
• Familiarity with SAP, LIMS, Maximo, Syncade, DeltaV and Veeva Vault.

Responsibilities

• Provide leadership to a team of Quality managers overseeing QA for technology transfer and validation.
• Supervise change controls, protocols/reports, investigations and maintenance planning.
• Coordinate audits with regulatory authorities and customers.
• Interface with cross-functional teams in tech transfer meetings.
• Track tech transfer milestones and allocate resources accordingly.
• Represent quality in governance and project meetings.
• Support risk assessments and corrective actions with QA and field ops.
• Develop and manage training for direct reports on related processes.
• Prepare site for regulatory inspections and respond to findings.

Skills

Leadership

Communication

Quality assurance

cGMP knowledge

SAP

LIMS

Maximo

Syncade

DeltaV

Veeva Vault

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 to lead a team overseeing quality control projects, tech transfer, and site operations. You will manage QA for validation, automation and site maintenance programs, and support regulatory audits.

The role requires substantial biopharma QA/tech transfer experience, leadership, and strong knowledge of cGMPs, with a focus on high-quality product delivery and regulatory compliance.