Sr. Manager Quality and Risk Management - Princeton - ACADIA Pharmaceuticals

    ACADIA Pharmaceuticals
    ACADIA Pharmaceuticals Princeton

    4 days ago

    Description
    The Sr. Manager Quality and Risk Management role at Acadia Pharmaceuticals is responsible for managing Research and Development (R&D) Quality Risk Management activities, including quality control of clinical trials execution in a Good Clinical Practices (GCP) regulated environment.

    Key responsibilities include contributing to effective quality control and QRM, creating new process compliance indicators, leading study teams to translate R&D risks into Key Risk Indicators (KRIs), working with colleagues in Quality and operational units to resolve concerns and opportunities for improvement, maintaining the R&D QRM framework, ensuring continuous improvement of clinical trial processes associated SOPs within Clinical Operations, Data Management Pharmacovigilance Critical factors,

    Supporting or leading implementation of ICH updates Process Improvement initiatives based on QRM data analysis criteria identifying design efficiencies based critical study program CSP data Contributing Health Authority Inspections state inspection readiness

    Educational background Bachelor's or master's degree relevant field such as biology nursing neuroscience psychology biochemistry clinical pharmacology related Equivalent combination education applicable job experience considered Minimum years pharmaceutical Healthcare experience GCP regulated environment including some Experience R D Quality Assurance systems regulations Abilities required Excellent verbal written communication skills ability work independently cross-functional teams Flexibility switch projects assignments manage multiple daily Ability interpret apply practical knowledge regulations guidelines immediate resolution compliance issues proactive management regulatory/compliance risk mitigation supervision needed Travel percentage time

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