Offer summary

Qualifications:

Minimum 8 years of experience in Quality Assurance within the life sciences industry., Strong knowledge of GCP, GxP standards, and clinical QA practices., Experience supporting Post-Trial Access, Expanded Access, or Compassionate Use programs is preferred., Excellent communication skills and ability to work independently in a dynamic environment..

Key responsibilities:

Provide QA oversight for the development and implementation of the WTA/Post-Trial Access program.

Review study documentation, informed consent forms, labeling, and supply chain processes for quality and compliance.

Ensure the program aligns with GCP, GxP standards, and regulatory requirements.

Collaborate with cross-functional teams to develop SOPs, conduct risk assessments, and prepare for audits.

Job description

This is a remote position. This is a temporary x-month contracted 1099 position with no benefits.”

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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