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1 result for Consultant in San Francisco, CA
- San Francisco, CA
- remote
- Temporary
- 65 - 80 USD / Hourly
- We are looking for an experienced Project Manager/Sr. Consultant to contribute to the development of a robust Quality Management System tailored for pharmaceutical and life sciences applications. In this role, you will collaborate closely with AI engineers to ensure compliance with GxP regulations, while driving the creation and implementation of essential documentation and processes. This is a long-term contract position based in San Francisco, California.<br><br>Responsibilities:<br>• Lead the creation of a Quality Management System, including authoring the Quality Manual, SOPs, and validation packages.<br>• Collaborate with engineers to ensure clinical data workflows align with GxP compliance requirements.<br>• Serve as the primary quality function, managing documentation and compliance processes from the ground up.<br>• Represent the organization during audits, defending the quality systems and documentation developed.<br>• Educate engineering teams on the importance of GxP regulations and compliance standards.<br>• Make informed decisions regarding scoping and implementation based on regulatory knowledge, including 21 CFR Part 11 and EU Annex 11.<br>• Develop strategies to address vendor qualification audit findings and implement remediation plans.<br>• Utilize Agile Scrum methodologies to manage project timelines and deliverables efficiently.<br>• Oversee IT project management tasks, ensuring alignment with overall compliance objectives.<br>• Use tools such as Atlassian Jira to track project progress and maintain transparency across teams.
- 2026-03-13T00:00:00Z