MQSA Regulatory Intelligence & Standards Lead

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

Job summary

Bristol Myers Squibb in New Brunswick, NJ, seeks an experienced leader for Regulatory Intelligence and Compliance Alignment within the CCS/SA program. You will own the global regulatory surveillance program, translate insights into actionable guidance, and partner with Health Authorities to support inspections and filings.

The role emphasizes enterprise governance, cross-site collaboration, and strategy development to ensure sterility assurance and regulatory readiness across manufacturing sites

Qualifications

• Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry or related field.
• Bachelor's degree or equivalent in a relevant scientific discipline with extensive experience.
• Strong knowledge of cGMPs, regulatory standards, and quality systems.

Responsibilities

• Lead enterprise CCS/SA governance and regulatory alignment across sites.
• Own global regulatory intelligence deliverables and change impact assessments.
• Support Health Authority inspections and regulatory filings related to CCS/SA.
• Develop strategy, roadmaps, and performance measures for CCS/SA.
• Coordinate with external partners to ensure compliance with standards.

Skills

Regulatory compliance

Inspection readiness

Governance frameworks

Cross-functional leadership

Strategic roadmap

Education

B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related discipline

Bachelor's degree or equivalent in a relevant scientific discipline

Job description

Bristol Myers Squibb in New Brunswick, NJ, seeks an experienced leader for Regulatory Intelligence and Compliance Alignment within the CCS/SA program. You will own the global regulatory surveillance program, translate insights into actionable guidance, and partner with Health Authorities to support inspections and filings.

The role emphasizes enterprise governance, cross-site collaboration, and strategy development to ensure sterility assurance and regulatory readiness across manufacturing sites