Director, Head of PV and REMS Compliance

Praxy; Madison (NJ); Hybrid; USD 218,000 - 264,000; Full time

Benefits offered by this job

Wellbeing benefits

Retirement plan

Comprehensive insurance

Job summary

Bristol Myers Squibb seeks a senior leader to drive Pharmacovigilance quality and compliance across global safety processes in Madison, NJ. This role oversees REMS programs, risk-based monitoring, and regulatory alignment to ensure inspection readiness and continuous improvement.

The role requires ~10 years in pharmacovigilance with 7+ years in progressive leadership, plus a strong scientific background and experience with AI-enabled quality initiatives.

Qualifications

• Pharmacovigilance leadership experience in quality/compliance.
• Strong understanding of global GVP regulations and inspectorate expectations.
• Experience leveraging AI/digital tools to improve PV and REMS processes.

Responsibilities

• Lead PV quality and compliance oversight across safety outputs.
• Oversee REMS compliance programs, readiness, and tooling.
• Govern PV quality governance and enterprise quality initiatives.
• Partner with senior stakeholders to drive strategy and risk-based improvements.

Skills

PV Leadership

Quality Governance

Regulatory Compliance

Cross-functional Leadership

Digital Tools & AI

Education

Bachelor's degree in science

Post-graduate education preferred

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"- a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

Accountable for leading Patient Safety quality and compliance on all key PS processes through proactive, risk-based oversight and continuous monitoring of safety outputs, ensuring sustained compliance and quality excellence in alignment with global GVP regulations, regulatory guidance, and inspectorate expectations.

Position Responsibilities

Global PV Quality & Compliance Oversight

• Accountable for quality and compliance across Patient Safety through ongoing monitoring of safety deliverables, ensuring sustained compliance with worldwide GVP regulations, guidance, and inspectorate expectations.
• Ensures quality findings (i.e deviation, audit and inspection findings) and learnings are translated into sustainable system, process, and governance improvements across PV and REMS compliance programs.
• Assesses and prioritizes compliance and quality risks across PV and REMS activities, ensuring monitoring programs are risk-based and aligned with health authority expectations and internal controls.
• Oversee the design and execution of quality and compliance monitoring programs for safety outputs, including signal management, aggregate reports, and regulatory submissions.
• Drives innovative thinking and technology to move quality and compliance work into the future from transactional to analytical

US REMS Compliance Program Leadership

• Accountable for the quality, compliance, and effectiveness of REMS compliance and audit programs, ensuring alignment with FDA regulatory requirements, contractual obligations, and inspection expectations.
• Oversees REMS inspection readiness, compliance monitoring, and periodic assessments, ensuring risks are identified early and mitigated appropriately.
• Oversee the Business/System Owner for REMS compliance tools, ensuring validated, inspection-ready workflows for compliance monitoring, audits, documentation, and data integrity.

PV Quality Governance & Enterprise Quality Leadership

• Business Lead for the Safety Quality Management Forum and sponsor of the REMS Governance Forum ensuring effective governance, escalation, and transparency of PV and REMS quality and compliance risks.
• Contributes to Enterprise and other BMS Quality Councils, aligning PV quality strategy with broader R&D and enterprise quality objectives.

Leadership, Influence & Strategic Partnership

• Acts as a senior leader and subject matter expert for PV and US REMS compliance, providing strategic guidance to Patient Safety leadership and cross‑functional partners.
• Builds strong strategic partnerships across Patient Safety, R&D Quality, Regulatory Affairs, IT, and Legal to ensure aligned execution of PV and US REMS obligations, and to help shape Quality strategy.
• Develop and mentors high‑performing teams, fostering a culture of quality excellence, accountability, and continuous improvement.

Degree Requirements

Bachelor's degree with strong scientific background, post-graduate education preferred

Experience Requirements

Approximately 10 years of pharmacovigilance experience, with a minimum of 7 years of progressive leadership responsibility in pharmacovigilance, quality, compliance, or related disciplines.

Key Competency Requirements

Strategically leverages the full suite of BMS enterprise-approved AI and digital tools to drive simplification, automation, and effectiveness of quality and compliance programs within Patient Safety and sets clear expectations for adoption and responsible use across the PV and REMS Compliance organization.

Champions a culture of innovation and digital maturity by identifying, prioritizing, and enabling AI-driven and data-enabled solutions that improve operational efficiency, reduce manual burden, and strengthen compliance monitoring, risk assessment, and inspection readiness across the Pharmacovigilance Quality Management System.

Serves as an advocate for quality and compliance excellence, motivating and influencing departments and functions to consistently achieve the highest standards of regulatory compliance, inspection readiness, and patient safety.

Communicates a clear and compelling vision, supported by aligned strategies and priorities, to ensure consistent understanding and execution of global safety reporting and compliance requirements across stakeholders.

Builds, sustains, and leverages a strong network of quality and compliance leaders across BMS, demonstrating the ability to influence outcomes without direct authority and drive alignment across functions and geographies.

Applies deep regulatory and risk-based expertise to analyze, interpret, and anticipate the impact of global regulatory requirements and emerging risk factors on pharmacovigilance operations and ensures proactive mitigation strategies are implemented.

Develops and leads high-performing teams by setting clear expectations, fostering accountability, and embedding a continuous improvement mindset to elevate standards of quality and compliance.

Demonstrates highly effective and influential oral and written communication skills, coupled with strong interpersonal and stakeholder management capabilities, to engage senior leaders and cross‑functional partners.

Travel Required (nature and frequency). Enter "N/A" if not applicable.

Approximately 5-10% travel, including overnight required, including other BMS sites, or business partners/CROs to conduct various quality or inspection related activities; attend professional meetings and seminars.

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Madison - Giralda - NJ - US: $217,520 - $263,577 Princeton - NJ - US: $217,520 - $263,577

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned