Project Manager/Sr. Consultant

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.

Responsibilities:
• Lead the creation of a Quality Management System, including authoring the Quality Manual, SOPs, and validation packages.
• Collaborate with engineers to ensure clinical data workflows align with GxP compliance requirements.
• Serve as the primary quality function, managing documentation and compliance processes from the ground up.
• Represent the organization during audits, defending the quality systems and documentation developed.
• Educate engineering teams on the importance of GxP regulations and compliance standards.
• Make informed decisions regarding scoping and implementation based on regulatory knowledge, including 21 CFR Part 11 and EU Annex 11.
• Develop strategies to address vendor qualification audit findings and implement remediation plans.
• Utilize Agile Scrum methodologies to manage project timelines and deliverables efficiently.
• Oversee IT project management tasks, ensuring alignment with overall compliance objectives.
• Use tools such as Atlassian Jira to track project progress and maintain transparency across teams.
• Proven experience in creating and implementing Quality Management Systems for pharmaceutical or life sciences organizations.
• Deep understanding of GxP compliance, including 21 CFR Part 11 and EU Annex 11 regulations.
• Familiarity with Agile Scrum methodologies and their application in project management.
• PMP Certification or equivalent project management qualifications.
• Strong background in IT project management, with a focus on compliance-driven environments.
• Ability to work independently and effectively in fast-paced, engineering-focused settings.
• Expertise in using project management tools such as Atlassian Jira.
• Excellent communication skills to collaborate with engineering teams and represent the organization during audits.

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Robert Half will consider qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

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