Quality Assurance Consultant – Post-Trial Access (WTA) Program Support

We are seeking an experienced Quality Assurance (QA) Consultant to provide immediate support for the setup and quality oversight of a Post-Trial Access (PTA) or WTA (Without Treatment Alternative) program. This role is critical in ensuring the program is established in full compliance with GxP standards and applicable regulatory expectations. The consultant will collaborate with clinical operations, regulatory, and supply chain teams to guide quality documentation, SOP development, and QA review processes related to product access after trial completion.

Key Responsibilities:

• Provide QA oversight for the development and implementation of the WTA/Post-Trial Access program
• Review and provide quality input on study documentation, informed consent forms, labeling, and supply chain processes
• Ensure alignment with GCP and other applicable GxP standards throughout program setup
• Support or lead development and review of SOPs related to post-trial access
• Participate in risk assessments, document control, and audit preparedness activities
• Collaborate cross-functionally with Clinical, Regulatory, and Medical Affairs teams
• Provide QA guidance to ensure the program meets sponsor, IRB/ethics, and regulatory expectations

Qualifications:

• 8+ years of experience in Quality Assurance within the life sciences industry
• Strong background in GCP and clinical QA; prior experience supporting Expanded Access, Compassionate Use, or Post-Trial Access programs preferred
• Familiarity with global regulatory expectations (FDA, EMA, etc.) related to post-trial product use
• Strong written and verbal communication skills
• Ability to work independently in a fast-paced, evolving environment
• Experience in consulting roles strongly preferred

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