Senior QA Investigations & CAPA Lead

Bristol Myers Squibb EU Policy; South Hadley Falls (MA); On-site; USD 84,000 - 102,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Wellbeing support

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations to provide quality oversight of deviation investigations and CAPA programs at the Summit Cell Therapy Facility in NJ. The role ensures compliance with FDA/EMA guidelines and company policies while guiding cross-functional teams on root-cause analyses and corrective actions.

The role involves reviewing technical reports, facilitating inspection readiness, and mentoring teams.

Qualifications

• Bachelor's degree in STEM preferred; high school diploma/Associate with equivalent experience may be considered.
• 4+ years in a regulated industry with 1+ year deviation experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
• Demonstrated experience with electronic systems and databases.

Responsibilities

• Review and approve investigations/CAPAs/effectiveness checks at the manufacturing site.
• Review and approve technical reports including risk assessments and deviation system monitoring reports.
• Ensure corrective/preventive actions and effectiveness check plans address root causes.
• Perform routine reporting and analysis of metrics to ensure timely closure of quality events.
• Identify improvement opportunities and support site/team continuous improvement.
• Support internal and external inspections as required.
• Maintain compliance with learning plans and support training delivery.
• Lead meetings and represent function at cross-functional meetings.
• Build and maintain relationships with partner functions.

Skills

Policies interpretation

MS Office

Smartsheets

Data interpretation

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in STEM

High school diploma/Associate degree with experience

Tools

MS Office

Smartsheets

Electronic systems & databases

Job description

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations to provide quality oversight of deviation investigations and CAPA programs at the Summit Cell Therapy Facility in NJ. The role ensures compliance with FDA/EMA guidelines and company policies while guiding cross-functional teams on root-cause analyses and corrective actions.

The role involves reviewing technical reports, facilitating inspection readiness, and mentoring teams.