Program Manager Risk-based quality management (RBQM)

Job Title: Program Manager Risk-based quality management (RBQM)

Location: Onsite, San Jose CA – No remote

Job Type: FTE

Job Description:

Minimum 10 yrs

Primary skills:

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, cross‑functional 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 executive‑level reporting skill
 

Overview

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

Key Responsibilities

Lead end‑to‑end program governance, including steering committees, RAID logs, KPIs, and executive updates
Drive planning, roadmap execution, and cross‑functional 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