Quality Assurance Consultant – Post-Trial Access (WTA) Program Support - Full-time / Part-time

This is a remote position.#160;This is a temporary x-month contracted 1099 position with no benefits.#8221;br#160;pWe 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./ppKey Responsibilities:/pul type="disc"liProvide QA oversight for the development and implementation of the WTA/Post-Trial Access program/liliReview and provide quality input on study documentation, informed consent forms, labeling, and supply chain processes/liliEnsure alignment with GCP and other applicable GxP standards throughout program setup/liliSupport or lead development and review of SOPs related to post-trial access/liliParticipate in risk assessments, document control, and audit preparedness activities/liliCollaborate cross-functionally with Clinical, Regulatory, and Medical Affairs teams/liliProvide QA guidance to ensure the program meets sponsor, IRB/ethics, and regulatory expectations/li/ulpQualifications:/pul type="disc"li8+ years of experience in Quality Assurance within the life sciences industry/liliStrong background in GCP and clinical QA; prior experience supporting Expanded Access, Compassionate Use, or Post-Trial Access programs preferred/liliFamiliarity with global regulatory expectations (FDA, EMA, etc.) related to post-trial product use/liliStrong written and verbal communication skills/liliAbility to work independently in a fast-paced, evolving environment/liliExperience in consulting roles strongly preferred/li/ul This is a remote position.#160;This is a temporary x-month contracted 1099 position with no benefits.#8221;br#160;pWe 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./ppKey Responsibilities:/pul type="disc"liProvide QA oversight for the development and implementation of the WTA/Post-Trial Access program/liliReview and provide quality input on study documentation, informed consent forms, labeling, and supply chain processes/liliEnsure alignment with GCP and other applicable GxP standards throughout program setup/liliSupport or lead development and review of SOPs related to post-trial access/liliParticipate in risk assessments, document control, and audit preparedness activities/liliCollaborate cross-functionally with Clinical, Regulatory, and Medical Affairs teams/liliProvide QA guidance to ensure the program meets sponsor, IRB/ethics, and regulatory expectations/li/ulpQualifications:/pul type="disc"li8+ years of experience in Quality Assurance within the life sciences industry/liliStrong background in GCP and clinical QA; prior experience supporting Expanded Access, Compassionate Use, or Post-Trial Access programs preferred/liliFamiliarity with global regulatory expectations (FDA, EMA, etc.) related to post-trial product use/liliStrong written and verbal communication skills/liliAbility to work independently in a fast-paced, evolving environment/liliExperience in consulting roles strongly preferred/li/ul

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