Senior Program Manager Risk-based quality management (RBQM)
NextGen IT Inc.
San Jose, CA (In Person)
Full-Time
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Job Description
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
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