Senior Director, Aseptic Facilities & Quality Strategy

Bristol Myers Squibb; Dublin; On-site; EUR 155,000 - 188,000; Full time

Job summary

Bristol Myers Squibb is seeking an Associate Director to provide authoritative input on facility and utility design standards, risk assessments, and quality impact assessments. This role partners with MS&T on technology transfer, and with Engineering on capital projects, ensuring sterility and microbial control are integral to design and operations.

The ideal candidate has 10+ years in sterility assurance or aseptic manufacturing, with deep knowledge of regulatory expectations (FDA/EMA) and a

Qualifications

• Bachelor's degree in a scientific field required.
• 10+ years in sterility assurance or aseptic manufacturing.
• Experience defending technical positions during regulatory inspections.

Responsibilities

• Review global risk assessments and quality impact assessments.
• Lead business technical assessments for regulatory submissions.
• Oversee aseptic facility design and sterile utility systems oversight.

Skills

Aseptic processing

Environmental monitoring

Contamination control

Risk assessment (FMEA/HACCP)

Quality governance

Education

B.S. in Microbiology or related

Tools

Regulatory inspections

Lifecycle management

Job description

Bristol Myers Squibb is seeking an Associate Director to provide authoritative input on facility and utility design standards, risk assessments, and quality impact assessments. This role partners with MS&T on technology transfer, and with Engineering on capital projects, ensuring sterility and microbial control are integral to design and operations.

The ideal candidate has 10+ years in sterility assurance or aseptic manufacturing, with deep knowledge of regulatory expectations (FDA/EMA) and a