Quality Assurance Consultant â Post-Trial Access (WTA) Program Support
Quality Assurance Consultant â Post-Trial Access (WTA) Program Support
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Salary Not Disclosed
1 Vacancy
Job Description
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
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @. If you receive a message that seems suspicious or is not from our official domain please report it immediately to
Required Experience:
Senior IC
Employment Type
Full-Time
