Beacon Hill
Overview
Direct message the job poster from Beacon Hill Job Title:
Quality Assurance Senior Associate, R&D Location:
Fully Remote - they do want this person to be in the Greater Boston area Contract Term:
Contract through end of January 2026 Responsibilities
The R&D Quality Assurance Senior Specialist will work closely with the R&D functions in the execution of clinical trials and serve as the Quality Assurance representative for assigned studies. The R&D QA Senior Specialist will serve as quality SME and champion for high standards of regulatory compliance. This role will interact with external partners that support the clinical operations organization (CROs, laboratories, and other vendors) to ensure systems, processes, and outcomes follow applicable global regulations, guidelines, and standards. Review clinical study documents and check for consistency and compliance with client procedures as well as relevant regulations, standards and best practices. Act as Quality approver for deviations and CAPA related to assigned studies; provide guidance to R&D personnel performing investigations, root cause analyses, and CAPAs. Participate in cross-functional teams as SME in GCP to provide guidance and risk-based options that promote compliance. Function as Quality contact for audits of vendors and investigator sites as well as other study-specific audits (e.g., CSR and TMF). Identify quality process and system improvements and implement timely actions. Identify and communicate quality and compliance risks and participate in determination of appropriate planning to resolve and address issues and risks. Support the GCP inspection readiness (IR) strategy by leading IR activities for assigned studies and participating in regulatory inspections. Coordinate projects to successfully meet timelines. Other duties as assigned. Qualifications
Bachelor's degree, preferably in a Life Science discipline. Minimum 5 years of direct GCP Quality Assurance experience in regulated industry (pharma/biotech/CRO and medical device). Thorough knowledge of FDA and ICH Good Clinical Practices (GCP) requirements and regulations. Experience in supporting Regulatory Authority GCP inspections. Experience managing internal and contract personnel and external vendors and auditors. Ability to communicate effectively and non-confrontationally with internal departments. Proven ability to work in a fast-paced environment, handling multiple demands and shifting priorities with flexibility. Employment details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance
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Direct message the job poster from Beacon Hill Job Title:
Quality Assurance Senior Associate, R&D Location:
Fully Remote - they do want this person to be in the Greater Boston area Contract Term:
Contract through end of January 2026 Responsibilities
The R&D Quality Assurance Senior Specialist will work closely with the R&D functions in the execution of clinical trials and serve as the Quality Assurance representative for assigned studies. The R&D QA Senior Specialist will serve as quality SME and champion for high standards of regulatory compliance. This role will interact with external partners that support the clinical operations organization (CROs, laboratories, and other vendors) to ensure systems, processes, and outcomes follow applicable global regulations, guidelines, and standards. Review clinical study documents and check for consistency and compliance with client procedures as well as relevant regulations, standards and best practices. Act as Quality approver for deviations and CAPA related to assigned studies; provide guidance to R&D personnel performing investigations, root cause analyses, and CAPAs. Participate in cross-functional teams as SME in GCP to provide guidance and risk-based options that promote compliance. Function as Quality contact for audits of vendors and investigator sites as well as other study-specific audits (e.g., CSR and TMF). Identify quality process and system improvements and implement timely actions. Identify and communicate quality and compliance risks and participate in determination of appropriate planning to resolve and address issues and risks. Support the GCP inspection readiness (IR) strategy by leading IR activities for assigned studies and participating in regulatory inspections. Coordinate projects to successfully meet timelines. Other duties as assigned. Qualifications
Bachelor's degree, preferably in a Life Science discipline. Minimum 5 years of direct GCP Quality Assurance experience in regulated industry (pharma/biotech/CRO and medical device). Thorough knowledge of FDA and ICH Good Clinical Practices (GCP) requirements and regulations. Experience in supporting Regulatory Authority GCP inspections. Experience managing internal and contract personnel and external vendors and auditors. Ability to communicate effectively and non-confrontationally with internal departments. Proven ability to work in a fast-paced environment, handling multiple demands and shifting priorities with flexibility. Employment details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance
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