Quality Management Systems Project Manager

Job Summary

Leading the strategic build-out and lifecycle management of Quality Management System documentation, the remote Project Manager, Quality Management Systems & Documentation will manage controlled documentation initiatives, coordinate cross-functional stakeholders, and ensure compliance with regulatory requirements in a 6-12 month contract role.

Key responsibilities:

• Develop and maintain the enterprise SOP Development Master Plan and manage the end-to-end lifecycle of controlled procedures
• Coordinate cross-functional meetings to design, develop, and implement regulated processes while tracking documentation-related actions and milestones
• Ensure all documentation activities comply with applicable GxP regulations and company objectives, providing routine reports to the Sr. Director of Quality

Required qualifications:

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, Quality, Business, or Project Management
• 8+ years of experience in pharmaceutical, biotechnology, or medical device industries
• 3+ years of experience managing cross-functional projects
• Experience with controlled documentation and supporting GxP Quality Systems
• Experience implementing or managing electronic Quality Management Systems (eQMS)