PV & REMS Compliance Leader — Quality & Strategy

Bristol Myers Squibb; Madison (NJ); On-site; USD 218,000 - 264,000; Full time

Benefits offered by this job

Wellbeing support

Retirement and financial protection

Insurance offerings

Job summary

Bristol Myers Squibb seeks a senior leader to drive Patient Safety quality and REMS compliance, aligning with global GVP regulations. You will oversee risk-based monitoring, establish governance, and lead a cross-functional team across PV and regulatory functions to ensure inspection readiness and data integrity.

The role emphasizes strategic partnership, digital maturity, and continuous improvement to elevate safety operations and regulatory compliance across the organization.

Qualifications

• Bachelor’s degree with strong scientific background; post-graduate education preferred.
• Approximately 10 years of pharmacovigilance experience, with a minimum of 7 years of progressive leadership responsibility in pharmacovigilance, quality, compliance, or related disciplines.
• Strategic leadership and cross-functional collaboration to drive quality and compliance improvements.

Responsibilities

• Lead PV quality governance and enterprise quality leadership initiatives.
• Oversee REMS compliance programs, inspections readiness, and data integrity.
• Provide strategic guidance to Patient Safety leadership and cross-functional partners.

Skills

Leadership

Regulatory compliance

Pharmacovigilance

Quality management

Stakeholder management

AI tools/digital tools

Education

Bachelor's degree in science

Post-graduate education preferred

Tools

AI tools

Job description

Bristol Myers Squibb seeks a senior leader to drive Patient Safety quality and REMS compliance, aligning with global GVP regulations. You will oversee risk-based monitoring, establish governance, and lead a cross-functional team across PV and regulatory functions to ensure inspection readiness and data integrity.

The role emphasizes strategic partnership, digital maturity, and continuous improvement to elevate safety operations and regulatory compliance across the organization.