Senior Facility Quality Systems Specialist

Bristol Myers Squibb New Brunswick - NJ - US Updated 9 October 2026
PharmaBiotechMedTechClinical ResearchRegulatory AffairsQuality Assurancegmpemacroinformaws

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. The Senior Facility Quality Systems Specialist is a senior-level quality systems professional within Global Facilities Services (GFS) who owns facility Quality Management System (QMS) compliance across the full GFO site network, driving GFO's move toward a single, centralized quality systems standard in place of site-by-site management, and executing the concepts and priorities set by Quality Systems leadership into site- and program-level action. This role owns training programs, investigations, audits, and CAPA management, and drives continuous improvement activities. Across GFS facilities, this includes ensuring CMMS (Maximo) data integrity, owning cross-site compliance metrics governance and business operations projects supporting GFO's centralization strategy (e.g., CMMS standardization and digital change-control rollout), leading deployment of quality processes, quality systems documentation and protocol development, and directing training curriculum design and rollout. The successful candidate will apply strong working knowledge of GMP/GxP requirements, exercising independent judgment while partnering with and influencing cross-functional teams to advance a culture of quality, compliance, and operational excellence. This role will use AI-assisted tools to support day-to-day activities and will help shape how those tools are applied within the team, consistent with BMS's broader direction toward AI adoption across the organization. Key Responsibilities : Training Curriculum & Deployment Leadership Own review and validation of training curricula, ensuring assigned courses correctly map to role, process, or system, and recommend curriculum design changes. Lead coordination of training deployment during system rollouts and process changes, including accountability for completion tracking across affected personnel. Independently identify, resolve, and root-cause training gaps or curriculum discrepancies surfaced during audits, rollouts, or process reviews, and drive preventive action. Compliance & Quality Operations Own procedural documentation (SOPs/WIs) for assigned quality-related procedures, ensuring content accuracy, timely revision, and alignment with corporate quality requirements. Lead initiation, tracking, and resolution of deviations, non-conformances, CAPAs, and change controls, including complex or cross-site issues. Own quality metrics reporting and analysis, identifying trends and recommending corrective direction to leadership. Lead investigations, including scoping, root-cause analysis, documentation of findings, and follow-up action tracking. Lead risk assessments and continuous improvement initiatives, often as the facilitator or owner. Own facilities compliance metrics and dashboard/reporting tools such as Power BI, including design of new reporting views. Own day-to-day management of SharePoint tracking, collaboration sites, and QE reporting tools supporting the broader Quality Systems program. Audit & Inspection Readiness Lead internal and external audit support, including organizing information and responding to information requests, and serving as a point of contact for auditors. Own inspection readiness across areas of responsibility, proactively identifying gaps. Own audit observation tracking and drive closure of action items, escalating risk as needed. Own and maintain the Site Regulatory Agency Inspection Contact Lists across all GFO sites, ensuring quarterly updates, accuracy of primary/alternate agency contacts, and distribution to site security/reception teams for inspection readiness. Business Operations & Process Deployment Lead deployment of quality and compliance processes across facilities teams, translating program requirements into execution plans and sequencing work. Drive cross-stakeholder coordination and follow-up, resolving blockers independently and escalating only high-risk items. Own deliverables and milestones for assigned projects or program rollouts, including risk identification and mitigation planning. Own governance of cross-site business operations projects and compliance metrics that support GFO's centralized quality systems strategy (e.g., CMMS standardization, digital change-control rollout), including program-level status reporting to leadership and coordination across sites. Lead project coordination for facilities quality initiatives, including scheduling, status reporting, and stakeholder alignment. Represent the site or project in technical working sessions and workshops (e.g., system change management sessions), driving decisions and ensuring action item closure. Own application of AI-assisted tools to day-to-day activities and reporting decisions, and establish best practices for their use within the team, consistent with governance requirements. Cross-Functional Collaboration Partner with and influence Facilities, Engineering, Operations, IFM Partners, and site Quality organizations to drive compliance with quality requirements. Lead or actively shape team meetings and quality improvement projects. Champion adherence to standard operating procedures and quality standards, coaching others as needed. Provide informal guidance and knowledge transfer to less experienced team members on quality systems processes, documentation standards, and GMP/GxP requirements. Serve as facilities representative on Document Management, Training Management, and CMMS Management Communities of Practice (COP), executing program-level action items and providing site-level input. Data Integrity Lead data integrity initiatives and quality reviews. Own quarterly data integrity reviews of Maximo (CMMS) documentation and facilities asset/role-mapping data. Qualifications & Experience: Bachelor's degree required, or equivalent combination of education and relevant work experience. 4-5 years of experience in facilities, quality systems, or compliance required , including demonstrated independent ownership of QMS documentation, investigations, and/or CAPA activities in a GMP/GxP-regulated environment, with prior experience managing cross-site programs, metrics, or business operations initiatives preferred. Prior experience in pharmaceutical, biotechnology, medical device, or other regulated environments strongly preferred. Familiarity with CMMS platforms (e.g., Maximo) or electronic document management systems is a plus. Demonstrated independent ownership of document control, change control, or CAPA management processes in a GMP/GxP-regulated environment strongly preferred. Strong attention to detail and organizational skills, with the ability to identify systemic issues. <

Stand out for this role

NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.

Tailor my CV now — free to try