Senior Program Manager Risk-based quality management (RBQM)

Senior Program Manager Risk-based quality management (RBQM)

Onsite, San Jose CA No remote

Minimum 12 yrs

Primary skills:

• Life Sciences Domain
• Experience with RBQM/Central Monitoring platforms or analytics tools
• SAFe RTE, PMP, or Agile certifications
• 10+ years Program/Project Management in Life Sciences (required)
• compliance with GxP, ICH E6(R3), and validation standards
• Strong background in program governance, crossfunctional delivery, and stakeholder management
• Experience as RTE or Agile Program Manager in a scaled agile environment
• Solid understanding of ClinOps (Clinical Operations) processes, clinical data flows, and regulatory expectations
• Excellent communication and executivelevel reporting skill

Overview

Seeking a strong Program Manager with proven experience driving large, crossfunctional programs in Life Sciences. The ideal candidate has handson exposure to setting up program governance and/or played a Release Train Engineer (RTE) role in a scaled agile environment.

Key Responsibilities

• Lead endtoend program governance, including steering committees, RAID logs, KPIs, and executive updates
• Drive planning, roadmap execution, and crossfunctional alignment across ClinOps, Quality, Biometrics, Regulatory, and IT
• Serve as RTE for agile delivery teams (PI Planning, ART syncs, Scrum of Scrums, impediment removal)
• Support implementation of RBQM/Central Monitoring capabilities (risk scoring, KRIs/QTLs, centralized monitoring workflows)
• Ensure compliance with GxP, ICH E6(R3), and validation standards
• Manage vendors, global stakeholders, and delivery partners
• Promote continuous improvement, delivery predictability, and operational discipline