Associate Director, MQSA Regulatory Intelligence

Bristol Myers Squibb; Dublin; On-site; EUR 180,000 - 240,000; Full time

Job summary

Bristol Myers Squibb is seeking a senior Regulatory Intelligence & Compliance leader to drive enterprise CCS/SA governance, inspection readiness, and global regulatory strategy across the manufacturing network.

You will translate regulatory intelligence into actionable recommendations, support Health Authority engagements, and partner with site quality teams to ensure compliant operations and sustainable governance.

Qualifications

• Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry or a related field.
• Minimum 14 years of relevant experience in regulatory compliance within biopharma.
• Advanced knowledge of sterility assurance, contamination control, and aseptic processing.

Responsibilities

• Execute enterprise regulatory intelligence and surveillance program; monitor evolving global regulations and health authority expectations.
• Own and maintain governance documentation and standards across CCS/SA.
• Lead day-to-day inspection readiness activities and serve as SME during Health Authority inspections.
• Contribute to the CCS/SA roadmap, performance monitoring, and governance framework adoption.

Education

B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry

Bachelor’s degree in a related scientific discipline with extensive experience

Job description

Bristol Myers Squibb is seeking a senior Regulatory Intelligence & Compliance leader to drive enterprise CCS/SA governance, inspection readiness, and global regulatory strategy across the manufacturing network.

You will translate regulatory intelligence into actionable recommendations, support Health Authority engagements, and partner with site quality teams to ensure compliant operations and sustainable governance.