Quality Systems Project Manager

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Systems Project Manager in United States.

This role sits at the intersection of quality systems, regulatory compliance, and project management within a highly regulated pharmaceutical environment. You will support the Quality Risk Management (QRM) system owner in driving strategic initiatives and ensuring day-to-day compliance with GxP requirements and internal quality standards. Acting as a key coordination point, you will help structure and execute risk management activities across cross-functional teams while ensuring alignment with regulatory expectations. The position combines analytical oversight, process improvement, and hands-on project coordination in a data-driven quality environment. You will also contribute to continuous improvement efforts by analyzing quality system trends and supporting system enhancements. This is a high-impact role for someone who thrives in structured environments and enjoys improving complex quality systems.

• Provide primary project coordination and operational support for Quality Risk Management (QRM) processes, including strategic initiatives and continuous improvement activities.
• Collaborate with cross-functional teams to ensure timely, compliant execution of QRM activities across the organization.
• Support the Quality System owner in managing compliance-related actions, including CAPAs, audit findings, and inspection commitments.
• Analyze quality system data, KPIs, and trends to identify risks, gaps, and opportunities for improvement.
• Perform compliance and data quality checks to ensure adherence to GxP regulations, internal procedures, and industry standards.
• Assist in the development and maintenance of SOPs, work instructions, and training materials related to quality systems.
• Act as a super user for QRM tools and provide ongoing support to end users while contributing to system optimization and adoption.

Requirements

• Bachelor’s degree in life sciences, engineering, technology, or a related field, or equivalent experience.
• 5+ years of experience in quality systems, compliance, data quality, or quality operations within a GxP-regulated environment.
• Strong understanding of Quality Risk Management principles and pharmaceutical regulatory requirements.
• Experience with project management tools and methodologies, including coordination of cross-functional initiatives.
• Familiarity with risk assessment tools, DMAIC concepts, and Lean Six Sigma principles (certification preferred).
• Strong analytical and problem-solving skills with the ability to interpret complex data and trends.
• Excellent communication skills, with the ability to explain technical and regulatory concepts clearly.
• Proficiency in Microsoft Office tools (Excel, PowerPoint, Word, Outlook, Teams) and experience with data visualization tools.

Benefits

• Competitive hourly rate between $65–$70/hr (up to $75/hr for senior-level roles)
• Eligibility for overtime pay in accordance with applicable regulations
• Remote work arrangement within the United States
• Exposure to a leading pharmaceutical quality systems environment
• Opportunity to contribute to high-impact quality and compliance initiatives
• Collaboration with cross-functional scientific, regulatory, and operational teams
• Professional development in quality systems, risk management, and project leadership