Quality Specialist -GCP (Remote EST/CST)

Meet Life Sciences; Boston (MA); Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Specialist with expertise in Good Clinical Practice (GCP) to support a prominent biotech client focused on central nervous system (CNS) therapies. This remote role involves conducting quality reviews of clinical trial documentation, ensuring compliance with GCP regulations, and managing CAPAs, audits, and investigations. The ideal candidate will be proficient in Veeva Vault and possess a solid understanding of ICH-GCP guidelines. Join a dynamic team committed to excellence in quality assurance and contribute to meaningful advancements in the biotech field.

Qualifications

• Strong background in GCP with experience in clinical trial documentation review.
• Proficiency in Veeva Vault is required for this role.

Responsibilities

• Perform quality reviews of clinical trial documentation for GCP compliance.
• Support CAPA management and participate in audits and investigations.

Skills

Good Clinical Practice (GCP)

Attention to Detail

Critical Thinking

Communication Skills

Tools

Veeva Vault

Job description

Quality Specialist -GCP (Remote EST/CST)

Title: Quality Specialist (GCP Focus) – 6-Month Contract (Remote)

Overview:

We are searching for a Quality Specialist with a strong background in Good Clinical Practice (GCP) to support our well-funded biotech client focused in the central nervous system (CNS) space. The ideal candidate will have proven experience reviewing clinical documents, be highly proficient in Veeva Vault, and possess a solid understanding of GCP regulations. This role also involves supporting core QA activities including CAPAs, audits, and investigations.

Key Responsibilities:

• Perform detailed quality reviews of clinical trial documentation to ensure compliance with GCP, internal SOPs, and applicable regulatory requirements.
• Provide quality oversight and support across clinical studies throughout all phases.
• Support CAPA management by ensuring timely investigation, root cause analysis, and implementation of corrective actions.
• Assist in the review and management of deviations and quality investigations.
• Participate in internal and external audits, including inspection readiness efforts.
• Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Data Management, and other teams.
• Ensure complete, accurate, and compliant documentation within Veeva Vault and oversee timely completion of reviews.
• Contribute to continuous improvement initiatives to enhance quality systems and processes.

Requirements:

• Strong background in GCP with experience reviewing clinical trial documentation.
• Proficiency in using Veeva Vault is required.
• Solid understanding of ICH-GCP guidelines and global regulatory expectations.
• Experience supporting CAPAs, audits, investigations, and deviations in a QA role.
• Exceptional attention to detail, critical thinking, and communication skills.
• Ability to thrive in a remote work environment.
• Prior experience in the biotech, pharmaceutical, or CRO industry, ideally within CNS-focused programs, is preferred.

Seniority level

Associate

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing