Global Aseptic Design & Utilities Leader

Bristol-Myers Squibb Co; New Brunswick (NJ); On-site; USD 162,000 - 196,000; Full time

Benefits offered by this job

Wellbeing support

Flexible Time Off

11 holidays per year

Job summary

Bristol Myers Squibb Co. seeks a senior quality professional to lead aseptic processing, contamination control, and regulatory submissions in a diverse, global setting. The role focuses on risk assessment, design review, and inspection readiness across facilities and utilities.

The candidate will partner with Engineering, MS&T, Regulatory, and Supply Chain, driving Quality by Design and enterprise standards in a fast-paced pharmaceutical environment.

Qualifications

• Bachelor's degree in a scientific discipline such as Microbiology, Pharmaceutical Sciences, Biology.
• Progressive experience in sterility assurance and aseptic manufacturing across a regulated environment.
• Regulatory inspection experience (FDA/EMA) is highly desirable.

Responsibilities

• Review global risk assessments and quality impact assessments for contamination events.
• Lead complex Business Technical Assessments to support regulatory submissions.
• Develop investigation materials for aseptic and microbial control issues for inspections.
• Review and approve design packages and qualification protocols for cleanrooms and critical utilities.
• Provide oversight for sterile and non-sterile facility changes with contamination risk assessment.
• Drive Quality by Design and risk-based thinking across facility and lifecycle management.
• Support ExM governance, CCS documentation, and external manufacturing oversight as needed.

Skills

Quality Assurance

Regulatory Submissions

Aseptic Processing

Microbiology

Leadership

Education

Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biology

MS preferred in related field

Job description

Bristol Myers Squibb Co. seeks a senior quality professional to lead aseptic processing, contamination control, and regulatory submissions in a diverse, global setting. The role focuses on risk assessment, design review, and inspection readiness across facilities and utilities.

The candidate will partner with Engineering, MS&T, Regulatory, and Supply Chain, driving Quality by Design and enterprise standards in a fast-paced pharmaceutical environment.