
Senior QA Auditor (GCP)
R&D Partners • Texas, United States
Role & seniority: Senior QA Auditor (focus: GCP)
Stack/tools: Good Clinical Practice (GCP) compliance, regulatory standards, QA processes, audit reporting, cross-functional collaboration, training delivery
Top 3 responsibilities
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Conduct audits to ensure adherence to GCP guidelines and regulatory requirements
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Develop/implement quality assurance strategies and processes; prepare detailed audit reports
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Identify, resolve, and follow up on compliance issues; provide training on GCP standards
Must-have skills
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Proven QA experience with a focus on GCP
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Strong knowledge of regulatory requirements and industry standards
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Excellent communication, organizational skills; ability to manage multiple priorities independently
Nice-to-haves
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Relevant certifications/qualifications in clinical research or quality assurance
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Location & work type: Fully remote, anywhere in North America; must have legal authorization to work in the United States
Full Description
Drive clinical excellence as the guardian of GCP integrity and audit quality. R&D Partners is seeking a Senior QA Auditor with expertise in Good Clinical Practice (GCP). This role focuses on ensuring compliance with regulatory standards and maintaining quality assurance within clinical research processes. This is a fully remote role based anywhere in North America. Applicants must have legal authorization to work in the United States.
Responsibilities
- Conduct audits to ensure adherence to GCP guidelines and regulatory requirements.
- Collaborate with cross-functional teams to identify and resolve compliance issues.
- Develop and implement quality assurance strategies and processes.
- Provide training and guidance on GCP standards to internal teams.
- Prepare detailed audit reports and follow up on corrective actions.
Key Skills and Requirements
- Proven experience in Quality Assurance with a focus on GCP.
- Strong knowledge of regulatory requirements and industry standards.
- Excellent communication and organizational skills.
- Ability to work independently and manage multiple priorities.
- Relevant certifications or qualifications in clinical research or quality assurance are preferred.
- For more information, please contact Jacob Tutt.
- If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
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