Global Head, Aseptic Process & Contamination Control

Bristol Myers Squibb EU Policy; New Brunswick (NJ); On-site; USD 219,000 - 265,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Wellbeing and health benefits

Job summary

Bristol Myers Squibb is seeking a senior leader to own enterprise sterility risk management, regulatory inspection support, and cross-functional strategy across global manufacturing. You will shape risk models, drive CAPA programs, and partner with QA, MS&T, and operations to ensure robust contamination control.

Travel domestically and internationally is expected. The role requires deep expertise in aseptic processing, regulatory submissions, and leadership of global teams within GMP

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 12+ years of progressive experience in pharmaceutical manufacturing, quality, sterility assurance, or microbiology within a regulated GMP environment
• 7+ years of senior/leadership experience with direct accountability for sterile manufacture
• Experience with Single-Use Technologies (SUT), biologics, or complex drug product manufacturing strongly preferred
• Proven track record leading cross-functional teams across global, matrixed organizations

Responsibilities

• Define and maintain enterprise sterility and microbial failure model library with risk classification taxonomy
• Establish and own contamination control strategy aligned with regulatory expectations
• Develop and standardize risk assessment methodologies and tools used across global sites
• Perform Global Microbial risk assessments and help build remediation action plans
• Provide authoritative review and sign-off on quality decisions affecting sterility assurance
• Lead or support CAPA development and effectiveness monitoring for contamination trends
• Define and govern APS/media fill strategy and oversee smoke study program

Skills

Scientific communication

Regulatory inspection

Cross-functional leadership

Strategic thinking

Travel willingness

Education

Bachelor's degree in Microbiology/related field

Tools

ASME BPE

EHEDG

FMEA

Job description

Bristol Myers Squibb is seeking a senior leader to own enterprise sterility risk management, regulatory inspection support, and cross-functional strategy across global manufacturing. You will shape risk models, drive CAPA programs, and partner with QA, MS&T, and operations to ensure robust contamination control.

Travel domestically and internationally is expected. The role requires deep expertise in aseptic processing, regulatory submissions, and leadership of global teams within GMP