Senior Specialist, Lab Compliance; GLP & Bioanalysis

Position Summary

The Senior Specialist, Lab Compliance (GLP & Bioanalysis) supports broad GLP & Bioanalysis compliance activities to ensure regulations, standards, and requirements are met based on assay intended use within Bioanalysis. This role ensures robust, compliant lab services and data integrity across internal and external CRO laboratories, including vendor qualification and performance monitoring. The position supports audit readiness, global regulatory inspections, and continuous improvement initiatives and serves as a support and training resource for the Bioanalysis organization.

The role works with cross‑functional stakeholders to support the BMS pipeline and business objectives.

• Support GLP & Bioanalysis compliance efforts across the organization to apply the required GxP standards based on intended lab use.
• Maintain audit/inspection readiness of internal regulated Bioanalysis labs; participate in laboratory walkthroughs, document quality control, and audits or site visits.
• Manage GLP quality systems, best practices, and training programs.
• Manage vendor compliance for Bioanalysis labs according to established processes.
• Ensure resolution of deviations, CAPAs, and change controls in internal and external labs with timely corrective actions.
• Provide document management support within the Electronic Document Management System (EDMS).
• Demonstrate BMS values in all actions and team interactions.

• Bachelor’s Degree with 4+ years of lab compliance, bioanalysis, or industry experience OR Master’s Degree with 2+ years of lab compliance, bioanalysis, or industry experience.
• Knowledge of GLP, GCP, GMP, GDP, FDA Quality System Regulation, IVDR, and Data Integrity principles (ALCOA+).
• Experience training team members on procedures, processes, tools, or applications.
• Experience managing vendors/CROs, audit/inspection readiness, and regulatory submissions.
• Experience with biomarker assay technologies, systems, and platforms.
• Understanding of procedural documents and completion of forms, logs, and templates within a document hierarchy.
• Familiarity with digital quality systems such as LIMS/ELN, eQMS, audit-management platforms, and data integrity tools.
• Proficiency with Microsoft Office, SharePoint, and Adobe Acrobat.
• Effective communication, cross‑functional collaboration, and cross‑cultural awareness.
• Organizational, analytical, and planning skills.
• Ability to work independently or within cross‑functional teams in a fast‑paced environment with attention to detail and high‑quality results.

Princeton - NJ - US: $84,770 - $102,722 (starting compensation for full‑time positions). Additional incentive cash and stock opportunities may be available. Final compensation will reflect demonstrated experience.

• Health, medical, pharmacy, dental, and vision coverage.
• Well‑being support programs, employee assistance programs, and a well‑being account.
• Retirement and savings plans, short‑term and long‑term disability, life insurance, and legal support.
• Paid time off including flexible or unlimited time for exempt employees, paid vacation, national holidays, and optional holidays for certain locations.
• Additional paid sick time, volunteer days, and summer hours flexibility where eligible.

BMS is an equal opportunity employer that welcomes applications from all qualified individuals, including those with disabilities. The company provides reasonable workplace accommodations and supports inclusive hiring practices. For more information on equal employment opportunity and accessibility, please refer to the BMS equal‑employment‑opportunity statement.