Senior Specialist, Lab Compliance; GLP & Bioanalysis

Position: Senior Specialist, Lab Compliance (GLP & Bioanalysis)
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Position Summary

The Senior Specialist, Lab Compliance (GLP & Bioanalysis) is accountable to support the broad GLP & Bioanalysis compliance activities to ensure regulations, standards, and requirements are met based on assay intended use within Bioanalysis. This role supports laboratories to ensure robust, compliant lab services and data integrity across internal and external CROs laboratories, including vendor qualification and performance monitoring. The position supports activities for audit readiness, global regulatory inspections, and continuous improvement initiatives, partnering cross-functionally to support the organization's pipeline and business objectives.

The position is to serve as a support and training resource for Bioanalysis organization and provide Quality Management System (QMS) role support within other applications and databases. This role will work with cross-functional stakeholders for various compliance and/or operational efforts in support of the BMS pipeline.

Key Responsibilities:

* GLP & Bioanalysis Compliance Support Supports broader compliance efforts across Bioanalysis to ensure the requisite GxP standards are applied based on the intended use within the internal and/or external lab.

* Supports activities to maintain state of audit/inspection readiness of internal regulated Bioanalysis lab; may participate in laboratory walkthroughs, QC of associated documentation, and/or audits/inspections/site visits.

* Support management of the GLP quality systems, best practices, and training programs.

* Supports Bioanalysis vendor compliance management activities according to established processes.

* Support Bioanalysis labs to ensure resolution of deviations, CAPAs, and change controls across internal and external labs, ensuring timely and effective corrective actions.

* Provides document management support within Electronic Document Management System (EDMS).

* Assure that BMS values are demonstrated in all aspects of individual actions and team interactions.

Qualifications & Experience

* 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

* General knowledge in GLP and bioanalytical laboratory compliance and global quality standards and regulations, including GLP (OECD, ICH M10), GCP (ICH E6), GMP (21 CFR Parts 210/211), GDP (Good Documentation Practice), FDA Quality System Regulation (21 CFR Part 58)), IVDR (In Vitro Diagnostic Regulation) for EU compliance, Data Integrity principles (ALCOA+)

* Experience in training team members in procedures, processes, tools, or applications in an effective manner.

* Experience with vendor/CRO management, audit/inspection readiness, and regulatory submissions.

* Experience with various biomarker assay technologies, systems, and platforms.

* Understanding of compliance to various types and of procedural documents and completion of forms, logs, and templates within document hierarchy.

* Familiarity with digital quality systems such as LIMS/ELN, eQMS, audit-management platforms, and data integrity tools.

* Effective use of Microsoft Office suite, SharePoint, and Adobe Acrobat.

* Demonstrates effective communication skills, cross-functional collaboration skills, and a…