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…