Director, Head of PV and REMS Compliance

Bristol Myers Squibb•Princeton, NJ

1d•Hybrid

About The Position

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.

Requirements

Approximately 10 years of pharmacovigilance experience, with a minimum of 7 years of progressive leadership responsibility in pharmacovigilance, quality, compliance, or related disciplines.
Bachelor’s degree with strong scientific background, post-graduate education preferred

Nice To Haves

post-graduate education preferred

Responsibilities

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.
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.
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.
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.
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.
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.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays each year
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day