Job Description

About Us:

BostonGene’s mission is to power healthcare’s transition to personalized medicine using our AI-based molecular and immune profiling to improve the standard of care, accelerate research, and reduce the overall cost of cancer care.

BostonGene’s tests reveal key drivers of each tumor, including immune microenvironment properties, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies.

Position Summary

BostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards under BostonGene’s Quality Management System (QMS). This involves engaging and collaborating with cross-functional teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and BostonGene’s Standard Operating Procedures (SOPs) as appropriate.

Responsibilities

• Plan, coordinate, and direct the quality operations of the clinical laboratory to ensure accurate, quality-driven products and services are provided to customers.
• Act as a Clinical Quality Lead on clinical and non-clinical research studies by supporting project team compliance with applicable national and international regulatory standards and guidance.
• Develop Clinical Quality Assurance (CQA) Standard Operating Procedures and Policies.
• Reviews laboratory and supporting records, when applicable, to certify compliance with specifications and procedures.
• Perform final batch review and release.
• Assist in the review and approval of GxP documentation, such as Batch Records, Specifications, Test Methods, Protocols, Equipment Maintenance, Personnel Files, etc.
• Monitor performance of quality control systems to ensure effectiveness and efficiency.
• Works closely with Laboratory Management and Quality Control personnel to resolve open issues resulting from record reviews, internal audits of the facility and laboratory, and deviations.
• Support audits of the laboratory to assess adherence to CAP and NYSDOH Checklists, Study Protocols/Analytical Plans for clinical research and non-clinical research studies, and other applicable regulations and guidelines.
• Identify and propose improvements to the QMS.
• Participates in a collaborative review of laboratory SOPs and Work Instructions (WIs).
• Review and analyze Key Performance Indicator data and trends. Assess risk and propose remedial, corrective actions and/or preventive actions.
• Perform all other duties, as assigned.

Qualifications

• Bachelor’s Degree (or equivalent) required; a scientific discipline preferred.
• 5+ years of experience in a clinical laboratory setting including at least one year of supervisory experience.
• Must have prior experience in lab management.
• Experience with Quality Assurance oversight and support for all phases of Clinical and Production documentation and processes.
• Proven track record of successful management of quality assurance and compliance programs, including participation in audits and/or inspections.
• In-depth knowledge of quality event management processes and requirements, including investigation, root cause analysis, CAPA plan development and verification checks.
• Working knowledge of regulatory requirements/ standards (e.g., GCP, GLP, CAP, CLIA, NYSDOH, 21 CFR Part 11).
• Strong communication skills, both oral and written.
• Self-motivated and able to effectively prioritize and manage multiple projects.

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