Quality Assurance QMS Development and Program Manager

Quality Assurance QMS Development and Program Manager

• Full-time
• Shift: Day
• Max. Salary Region 2: 185600 USD
• Max. Salary Region 1: 218300 USD
• Ways of Working:
  Onsite - This job is fully onsite.
• Employee Type:
  Employee
• Min. Salary Region 1: 151700 USD
• Global Job Level (HCM):
  Professional 4 (11)
• Min. Salary Region 2: 128900 USD

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive
. As a global leader in robotic-assisted surgery and minimally invasive care
, our technologies—like the da Vinci surgical system and Ion
—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare
, you’ll find your purpose here.

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.

• 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

• 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

• Experience supporting early- through late-stage development programs
• Experience integrating QMS, LMS, and eQMS requirements…