Quality Assurance QMS Development and Program Manager

Intuitive • Sunnyvale, CA

1d

About The Position

The Quality Assurance QMS Development and Program Manager is responsible for supporting the design, implementation, and continuous improvement of the Quality Management System (QMS), including training and electronic QMS (eQMS) components, supporting early- to late-stage pharmaceutical development organization. This is an individual contributor, program-management role with no direct reports but one that requires the incumbent to work cross-functionally in a highly collaborative and supportive environment to ensure effective implementation of Intuitive Fluorescence Imaging’s Quality Management System across all functional areas and GxP disciplines. The position plays a hands-on role supporting the selection, validation, and implementation of QMS processes and enabling systems, including eQMS platforms, while working closely with cross-functional stakeholders to ensure regulatory compliance and operational effectiveness.

Requirements

• Bachelor’s degree in Life Sciences or related discipline
• 7+ years of experience in pharmaceutical or biotechnology quality assurance
• Direct experience building, implementing, or significantly enhancing a QMS
• Experience supporting selection, validation, and implementation of QMS processes and/or eQMS platforms
• Hands-on experience implementing or managing a Training Management System (LMS)
• Strong working knowledge of FDA, EMA, and ICH GxP requirements
• Experience with SOP management, CAPA, deviation management, and change control

Nice To Haves

• Experience supporting early- through late-stage development programs
• Experience integrating QMS, LMS, and eQMS requirements across GCP, GLP, GVP, and CMC
• Experience preparing organizations for regulatory inspections
• Familiarity with common eQMS platforms

Responsibilities

• Support the design, implementation, and maintenance of the enterprise QMS in alignment with FDA, EMA, and ICH requirements
• Develop and manage core QMS elements including SOPs, work instructions, templates, and controlled records
• Support the selection, validation, configuration, and implementation of QMS processes and enabling systems, including eQMS components
• Establish and maintain the Training Management System (LMS) as an integrated component of the QMS
• Define training requirements, curricula, role-based training matrices, and training effectiveness measures
• Ensure timely assignment, completion, tracking, and documentation of GxP training
• Lead SOP lifecycle management, including authoring, review, approval, periodic review, and retirement
• Establish and maintain document control, change management, deviation, and CAPA processes
• Support root cause analysis, CAPA development, effectiveness checks, and closure
• Establish QMS governance processes including management review, quality metrics, and reporting
• Support internal audits, vendor audits, and inspection readiness related to QMS and training compliance
• Ensure QMS and LMS documentation supports regulatory inspections and partner audits
• Provide hands-on QMS and training guidance to cross-functional teams

What This Job Offers

• Job Type: Full-time
• Career Level: Manager