Associate Director, Aseptic Operations & Quality Governance

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

Benefits offered by this job

Medical insurance

Retirement plan

Paid holidays

Flexible time off

Job summary

Bristol Myers Squibb is seeking an Associate Director, Aseptic Operational Support with expansive expertise in aseptic processing and contamination control to guide facility and utility design, qualification, and regulatory readiness. This role focuses on integrating CCS requirements into design and ensuring sterilization and WFI systems meet stringent standards.

The position requires 10+ years in sterility assurance, with at least 4 years in leadership, and involves collaboration with MS&T,

Qualifications

• Required: BS in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
• 10+ years in sterility assurance, aseptic manufacturing or pharmaceutical quality; at least 4 years in a leadership/enterprise role.
• Strong experience defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA).

Responsibilities

• Review and approve global risk assessments and quality impact assessments for facilities and utilities.
• Serve as Global Quality SME for aseptic facility/utility design and issue design packages, URS, DQ, change controls.
• Own sterilization standards and SUT knowledge; ensure regulatory alignment and design for CCS, WFI, PW, sterilization validation.

Skills

Aseptic processing

Contamination control

Risk assessment

Regulatory inspections

Quality by Design

Cross-functional collaboration

Education

BS in Microbiology

Job description

Bristol Myers Squibb is seeking an Associate Director, Aseptic Operational Support with expansive expertise in aseptic processing and contamination control to guide facility and utility design, qualification, and regulatory readiness. This role focuses on integrating CCS requirements into design and ensuring sterilization and WFI systems meet stringent standards.

The position requires 10+ years in sterility assurance, with at least 4 years in leadership, and involves collaboration with MS&T,