EVERSANA

  • Director, Quality Assurance

    Job Locations US-CA-Emeryville
    Job ID
    2018-2103
    # of Openings
    1
    Category
    Hidden (37430)
  • Overview

    OUR CULTURAL BELIEFS

    Patient Minded I act with the patient’s best interest in mind.

    Client Delight I own every client experience and its impact on results.

    Take Action I am empowered and empower others to act now.

    Grow Talent I own my development and invest in the development of others. 

    Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

    Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

    Own It I hold myself and others accountable for results.

     

    THE POSITION:

    The most important aspect of this position is to take responsibility to assure compliance to client and regulatory requirements, and provide tools to foster Performance & Quality Improvement (PQI) efforts, support and assist in the development and management of quality systems in Emeryville in addition to conducting independent internal and external audits and to assess compliance with regulations, guidelines and operating procedures.

     

    Responsibilities

    ESSENTIAL DUTIES & RESPONSIBILITIES:

    • Continuously identify opportunities to improve operational processes, build in quality and assist in implementation across and within the EVERSANA – Emeryville location
    • Help to ensure that EVERSANA – Emeryville quality systems meet or exceed best practices and regulatory standards and participate in development strategies and plans to maintain and improve these systems
    • Live the EVERSANA corporate values of caring, creativity, commitment and collaborative behavior
    • Provide support and assist in the development and management of GxP (i.e., GVP, GCP, GDP, GAP) activities and quality systems at EVERSANA – Emeryville, including conducting independent internal and external audits to assess compliance with regulations, guidelines and operating procedures
    • Lead the implementation and support compliance documentation and controls within a standard quality management system across EVERSANA – Emeryville
    • Support activities to evaluate regulatory compliance
    • Provide support for Company regulatory GxP inspections, client qualification audits and routine/ad hoc audits; conduct external qualification and ongoing audits of vendors and client partners as needed
    • Provide client quality system and quality gap analysis consultation as requested
    • Partner with senior leadership to develop GxP audit strategy and implement inspection and audit readiness activities
    • Help prepare inspection and audit responses and ensure tracking of corrective actions to closure
    • Ensure that post inspection/audit commitments are tracked and completed on time
    • Assist in the implementation of corrective/preventive action plans and quality system improvements
    • Interact professionally with company management, internal departments, third parties and others relative to various quality initiatives
    • Recommend changes in standard procedures to reflect technological changes, regulatory trends and best practices
    • Provide support for collaborative efforts with EVERSANA Corporate Quality leadership in overarching corporate quality initiatives

     

    Qualifications

    MINIMUM qualifications:

    The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

     

    • MS, MPH, PhD or similar advanced professional Degree in healthcare or the life sciences preferred Minimum 7+ years in quality assurance in GxP environment (i.e., GVP, GCP, GDP, GAP)
    • Experience in pharmacovigilance and/or medical communications preferred.
    • Minimum 7+ years of experience in conducting audits.
    • Ability to communicate effectively at all levels of the organization and with key client and vendor stakeholders
    • Ability to align internal practices and partner across EVERSANA – Emeryville for high performance

    Preferred qualifications:

    • Advanced professional Degree in healthcare or the life sciences preferred
    • Knowledge of quality assurance in GxP environment (i.e., GVP, GCP, GDP, GAP)
    • Experience in designing and implementing quality systems and procedures and audit conduct/readiness for the pharmaceutical and biotechnology industry or Quality Certifications
    • Knowledge of Microsoft Excel, Word, and PowerPoint, LMS, TrackWise

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