Regulatory Intelligence & Standards Lead (Associate Director)

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

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

Wellbeing support

Job summary

Bristol-Myers Squibb Co is seeking an Associate Director, MQSA Regulatory Intelligence and Standards to lead enterprise CCS/SA governance, regulatory intelligence, and inspection readiness across the commercial manufacturing network in the United States. You will drive compliance strategies, stakeholder engagement, and cross-site standardization.

Role emphasizes collaboration with Health Authorities, site quality teams, and external partners to ensure robust sterility assurance and regulatory

Qualifications

• Demonstrates advanced knowledge and practical experience of sterility assurance and contamination control strategy in a biopharmaceutical setting.
• Experience with aseptic processing and regulatory requirements related to CCS/SA regulatory compliance.
• Extensive engagement with global Health Authorities (FDA, EMA, PMDA) in inspections, agency responses, and filings.
• Experience developing and implementing enterprise governance frameworks, global standards, policies, and decision frameworks.

Responsibilities

• Lead enterprise CCS/SA governance and standards across commercial manufacturing environments.
• Own compliance gap assessments and applicability matrices for aseptic and sterility assurance.
• Coordinate with site quality teams to ensure scalable, sustainable implementation of enterprise standards.
• Support regulatory engagement strategy with Health Authorities and industry bodies during inspections and inquiries.
• Translate regulatory intelligence into actionable recommendations and briefing documents.

Skills

Sterility assurance

Aseptic processing

Regulatory compliance

Health Authority engagement

Contamination control

Education

Bachelor’s degree or equivalent in Microbiology/Life Sciences/Biology

B.S. in Microbiology or Pharmaceutical Sciences

Job description

Bristol-Myers Squibb Co is seeking an Associate Director, MQSA Regulatory Intelligence and Standards to lead enterprise CCS/SA governance, regulatory intelligence, and inspection readiness across the commercial manufacturing network in the United States. You will drive compliance strategies, stakeholder engagement, and cross-site standardization.

Role emphasizes collaboration with Health Authorities, site quality teams, and external partners to ensure robust sterility assurance and regulatory