Biopharma QA Operations Leader — Tech Transfer

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

Benefits offered by this job

Health Coverage

401(k) plan

Disability Insurance

Life Insurance

Travel protection

Legal support

Paid Time Off

Summer hours

Volunteer days

Job summary

Bristol Myers Squibb in Devens, MA seeks a Senior Manager QA Technical Operations to lead a team overseeing Change Controls, Validation, Tech Transfer and QA for Automation. You will ensure compliance with US/EU cGMP and coordinate audits with internal stakeholders.

The ideal candidate has a BS in science/engineering and 8+ years in biopharma operations, with 2+ years in people management, and a track record building high-performance teams within biotech manufacturing environments.

Qualifications

• B.S. in science, engineering, biochemistry or related discipline.
• 8+ years’ experience in biopharmaceutical operations with 2 years of management desirable.
• Experience building and growing an organization into a high-performance team.
• Strong background in quality assurance operations and cGMP compliance for commercial biologics manufacturing.
• Knowledge of biotech bulk and finished product manufacturing and analytical testing.

Responsibilities

• Provides direct supervision of personnel approving change controls, protocols/reports and investigations in support validation and automation teams.
• Oversees maintenance scheduling programs for preventive maintenance and calibrations.
• Represents quality in tech transfer governance meetings and in project meetings with stakeholders.
• Supports and approves tech transfer driven risk assessments and updates; coordinates with field quality operations.
• Develops and manages training curriculum for direct reports related to department processes.

Skills

Quality assurance

Leadership

Regulatory knowledge

Risk management

Cross-functional collaboration

Education

B.S. in science or engineering

Tools

SAP

LIMS

Maximo

Syncade

DeltaV

Veeva Vault

Job description

Bristol Myers Squibb in Devens, MA seeks a Senior Manager QA Technical Operations to lead a team overseeing Change Controls, Validation, Tech Transfer and QA for Automation. You will ensure compliance with US/EU cGMP and coordinate audits with internal stakeholders.

The ideal candidate has a BS in science/engineering and 8+ years in biopharma operations, with 2+ years in people management, and a track record building high-performance teams within biotech manufacturing environments.