Senior QA Investigations Specialist - Cell Therapy

VetJobs; Harvard (MA); On-site; USD 75,000 - 100,000; Full time

Job summary

The Senior Specialist, QA Investigations at Bristol Myers Squibb leads quality oversight of deviation investigations and CAPA records at the Devens Cell Therapy Facility. You ensure product quality in compliance with regulations, supporting internal and external inspections while delivering robust corrective actions.

You will collaborate with cross-functional teams, author and review technical reports, and drive continuous improvement through data analysis and effective training, while

Qualifications

• Bachelor's degree in STEM preferred; equivalent combinations may be considered.
• Experience with regulatory guidelines and quality systems in biotech/pharma.
• Ability to interpret data and assess CAPA effectiveness.

Responsibilities

• Review and approve investigations and CAPAs across multiple domains.
• Prepare and review technical reports, risk assessments, and monitoring outputs.
• Ensure robust corrective/preventive actions addressing root causes.
• Support inspections and deliver training content to cross-functional teams.
• Lead meetings and share data across functions.

Skills

Regulatory understanding

Data interpretation

Problem solving

Communication

Education

Bachelor's degree in STEM

Tools

MS Office

Smartsheets

Job description

The Senior Specialist, QA Investigations at Bristol Myers Squibb leads quality oversight of deviation investigations and CAPA records at the Devens Cell Therapy Facility. You ensure product quality in compliance with regulations, supporting internal and external inspections while delivering robust corrective actions.

You will collaborate with cross-functional teams, author and review technical reports, and drive continuous improvement through data analysis and effective training, while