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.
We are looking for an experienced Project Manager to join our team on a contract basis in Santa Clara, California. In this role, you will oversee smaller projects that contribute to the success of a larger, multi-year campus renovation initiative. This is an onsite position, requiring daily collaboration with stakeholders and vendors to ensure project goals are met efficiently and effectively.<br><br>Responsibilities:<br>• Manage and lead smaller project workstreams within a large-scale campus renovation effort.<br>• Collaborate closely with stakeholders, vendors, and team members to ensure seamless communication and project execution.<br>• Develop detailed project plans and monitor progress, addressing risks and issues proactively.<br>• Oversee project budgets, track expenditures, and provide accurate financial forecasts.<br>• Implement quality control measures to ensure deliverables meet high standards and stakeholder expectations.<br>• Coordinate with architects and technical experts to support the design and execution phases.<br>• Facilitate continuous improvement by identifying opportunities for enhanced project management practices.<br>• Ensure project timelines and milestones are achieved while adhering to budgetary constraints.<br>• Build and maintain strong relationships with clients and stakeholders to foster effective collaboration.<br>• Act as the main point of contact for onsite project activities and ensure alignment with overall objectives.