Associate Director, MQSA Regulatory Intelligence & Standards

Bristol Myers Squibb; New Brunswick (NJ); On-site; USD 164,000 - 199,000; Full time

Job summary

Bristol Myers Squibb is seeking an Associate Director to lead the enterprise CCS/SA regulatory intelligence and standards program. You will own global regulatory surveillance, maintain governance documents, and serve as the primary contact for Health Authority inspections and agency interactions.

The role requires extensive experience with cGMP, sterility assurance, and regulatory filings, plus strong cross-functional collaboration to ensure defensible, science-based compliance across sites.

Qualifications

• B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry or related field.
• Minimum 14 years of relevant experience in regulatory or quality roles.
• Strong knowledge of cGMP, sterility, aseptic processing and quality systems.

Responsibilities

• Lead enterprise regulatory intelligence and surveillance for CCS/SA with global health authority expectations.
• Maintain governance documentation, policies, and standards across CCS/SA.
• Coordinate inspections, agency inquiries, and regulatory filings related to CCS/SA matters.
• Translate regulatory findings into actionable recommendations and compliance actions.
• Develop and maintain training and competency tools for aseptic discipline across sites.

Skills

Regulatory intelligence

GxP compliance

Health Authority liaison

Documentation & writing

Cross-functional collaboration

Education

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

M.S. in Microbiology or related field (preferred)

Job description

Bristol Myers Squibb is seeking an Associate Director to lead the enterprise CCS/SA regulatory intelligence and standards program. You will own global regulatory surveillance, maintain governance documents, and serve as the primary contact for Health Authority inspections and agency interactions.

The role requires extensive experience with cGMP, sterility assurance, and regulatory filings, plus strong cross-functional collaboration to ensure defensible, science-based compliance across sites.