What are the responsibilities and job description for the Program Manager Risk-based quality management (RBQM) position at Falcon Smart IT (FalconSmartIT)?
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