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 based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements. The candidate will also be instrumental in quality assurance oversight and management activities of clinical trial operations to ensure BostonGene’s trials and services are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and BostonGene policies and procedures.

Responsibilities

● Serve as the GLP/GCP subject matter expert to cross-functional clinical trial teams to ensure that all quality and regulatory compliance activities were conducted in compliance with GCPs, SOPs, and ICH Guidelines.

● Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GLP/GCP.

● Interpret regulations, as appropriate for the phase of development, applying and/or adapting to internal policies and procedures.

● Completes clinical investigator site audits to assess adherence to the Study Protocol and associated documents, applicable regulations, and guidance/guidelines.

● Completes preclinical laboratory inspections as directed by study protocol.

● Assist in review/approval of other development program GxP documentation, such as: Master Batch Records, Specifications, Test Methods, Protocols, Reports, and SOPs.

● Identify and propose improvements to the QMS, ensuring compliance with all relevant quality standards and regulatory requirements.

● Serves as the Quality Lead for assigned BostonGene clinical research projects providing GCP compliance interpretation, consultation, and other support services necessary.

● Maintains knowledge of current industry trends, standards, and methodologies as it relates to Good Clinical Practice (GCP).

● Participates in a collaborative review of impacted SOPs/Work Instructions (WIs).

● Reviews and analyzes key Performance Indicator data and trends - Analyzes risk and proposes remedial, corrective and /or preventive actions.

● Liaise with BostonGene clinical functions and external parties including CROs, Vendors and investigator sites to promote high level of quality and consistency across and within programs.

● Provides QA review of protocols to identify operational risks and collaborates with the study team in development of risk mitigation strategies.

● Manages and/or leads domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards.

● Lead GCP/GLP inspections and assist in the surveillance inspections as assigned. Interact as required with regulatory agencies regarding GLP/GCLP matters.

● For assigned programs/ studies, develops risk-based plans, leads quality issue and deviation investigations, conduct root cause analysis and CAPA development and assists study teams in implementing corrective and preventive actions in support of sustainable compliance.

● Perform additional tasks, as assigned.

Qualifications

● BS degree in life science or technical discipline.

● 5 years of QA experience in a GCP setting for any phases of clinical trials in biotech or pharma required.

● Certification or completed GCP training.

● In-depth knowledge of ICH GCP and applicable global regulations and guidance for clinical development (e.g., FDA regulations).

● Proven track record of successful management of quality assurance and compliance programs, including participation in audits and/or inspections.

● In-depth knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness 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.