Co-op Global Quality - Commercial Specification Committee

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.

GQ Brand Enablement Science & Technology is a function of the Global Quality (GQ) group that serves Bristol-Myers Squibb's global business units by advancing brand performance and quality excellence through the integration of innovative science, data, and technology solutions. The Commercial Specification Committee (CSC) is an important and integrated quality function within GQ-BEST, responsible for establishing, maintaining, and governing the analytical controls and specifications strategy for commercial drug products across BMS's global portfolio.

CSC plays a critical role in bridging science, regulatory requirements, and manufacturing quality standards — ensuring that product specifications are scientifically sound, compliant with global regulatory frameworks, and aligned with the evolving needs of patients, markets, and business stakeholders. Through cross-functional collaboration with Regulatory Affairs, Drug Substance and Drug Product Development, Manufacturing Science & Technology, Product Quality, and Commercial Operations, CSC drives lifecycle management decisions that safeguard product quality and patient safety from launch through post-approval.

CSC enhances the colleague and customer experience by delivering the right insights, tools, and capabilities at the right time — in the most efficient and effective way. Strategic solutions aimed at optimizing end-to-end brand enablement capabilities, and which align to where our stakeholders and customers are evolving, are critical in ensuring the highest levels of quality and innovation in what is a rapidly changing environment.

The candidate(s) chosen for this position will become valued team members of one of several cross-functional, multi-divisional teams responsible for developing and executing Brand Enablement Science & Technology strategies for Bristol-Myers Squibb.

Pharmaceutical analytical controls strategy and specification lifecycle management; regulatory science principles (ICH quality guidelines); applied data analytics and automation tool development (e.g., Python, structured data pipelines, AI-assisted document review);
Digital & Technology Innovation;
Communications and Quality Systems operations.

Monday June 7, 2027 - Friday, August 13, 2027.

Madison, NJ (Giralda Farms)

• JoS Review Automation & Gap Analysis (Primary Focus)
• Support the development of a digital tool/workflow that evaluates draft JoS packages against global regulatory guidance (e.g., ICH quality guidelines) and internal BMS regulatory intelligence, flagging specifications that may require revision and/or additional data or stronger justifications
• Help define the logic and criteria the tool uses to assess a specification package — what counts as a gap, how severity is scored, and how findings are presented to CSC reviewers
• Test the tool against real and historical JoS packages, refine outputs based on reviewer feedback, and document how the tool’s assessments align with known Health Authority precedent
• Regulatory Intelligence as a Model Input
• Compile, organize, and maintain a structured knowledge…