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. Supports laboratories to ensure robust, compliant lab services and data integrity across internal and external CRO laboratories, including vendor qualification and performance monitoring. Partners cross-functionally for audit readiness, global regulatory inspections, continuous improvement, and QMS support;

serves as a support/training resource for Bioanalysis.

• Support GLP & Bioanalysis compliance efforts and application of requisite GxP standards.
• Maintain audit/inspection readiness for internal regulated Bioanalysis labs (walkthroughs, documentation QC, audits/inspections/site visits).
• Support GLP quality systems, best practices, and training programs.
• Support Bioanalysis vendor compliance management.
• Support resolution of deviations, CAPAs, and change controls; ensure timely corrective actions.
• Provide document management support within EDMS.

• Bachelor’s degree + 4+ years lab compliance/bioanalysis/industry experience OR Master’s degree + 2+ years.
• Knowledge of GLP, GCP, GMP, GDP, FDA QSR, IVDR, and data integrity (ALCOA+).
• Experience training others; vendor/CRO management; audit/inspection readiness; regulatory submissions.
• Familiarity with biomarker assay technologies and biomarker platforms.
• Understanding of compliance to procedural documents and document hierarchy (forms/logs/templates).
• Familiarity with LIMS/ELN, eQMS, audit-management platforms, and data integrity tools.
• Proficiency with Microsoft Office, SharePoint, and Adobe Acrobat.
• Strong communication, collaboration, organization, analytical/planning skills; ability to work independently and in cross-functional teams; attention to detail in fast-paced environments.

• Health coverage (medical, pharmacy, dental, vision)
• Wellbeing support programs (including EAP)
• Financial protection (401(k), disability, life/accident insurance, etc.)
• Paid Time Off (flexible time off for US exempt employees; vacation/holidays for Phoenix/Puerto Rico/Rayzebio hourly/non-exempt)