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    Senior Director BIS Quality - Boston, United States - Blackwomenintech

    Blackwomenintech
    Blackwomenintech Boston, United States

    3 weeks ago

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    Description
    As argenx continues to grow and evolve, we are looking for a Senior Director BIS Quality.

    The Senior Director BIS Quality is responsible for both the strategic direction as well as the day-to-day operations and coordination of all activities relating to the argenx Computer Systems Assurance (CSA) Process.

    This includes GxP systems, Regulated systems and non-GxP systems.

    This covers the entire life cycle of our systems and ranges from Initial Impact Assessment, through initial implementation, on-going/agile enhancements, managing Saas Release assessment and remediation, and solution retirement.

    Key Accountabilities/Responsibilities

    The position will have the following key responsibilities:

    Create a vision for BIS Quality that ensures the tools deployed by the BIS team deliver on their intended business value.

    Focus the BIS-Q strategy on assuring Quality and Patient Safety vs mere Compliance.
    Create a BIS-Quality framework that includes policies, procedures and instructions to support the entire argenx business.
    Ensure this framework and its components are fully aligned with the latest guidance from EMA/FDA/PDMA.
    Adopt a risk-adjusted approach to all BIS-Q activities.
    Liaise with the Computer Systems team in the QA function.
    Identify and manage our external CSV/A partners.

    Lead a small internal team, augmented by consultants, to ensure all daily activities are carried out on time and with the highest levels of quality.

    Liase with the appropriate BIS functions to perform the original CSA assessment, final implementation validation, AND define release management strategy for each platform.

    Monitor and ensure successful completion of Release Management of all argenx platforms/solutions.
    Monitor and ensure successful scheduling, execution and completion of all Periodic Reviews.

    Partner closely with the Lega/Compliance function at argenx for alignment with GDPR, HIPAA, and APPI guidelines as well as with Finance to ensure SOX, and others as needed.

    Desired Skills and Experience

    Minimum of 15 years working either in or near a biopharmaceutical medical or development sciences function, either within BIS/IT and/or in a development sciences function.

    Excellent Communication and Leadership skills to both create a vision and enroll all elements of the organization.
    Awareness of current regulations, draft and future directions, and Good Computing Standards.
    Understanding of the shift from CSV to CSA and the new GAMP5v2 guidelines.
    Experience as Assurance/Validation lead for computer systems in a regulated industry.
    Understanding of the industry landscape and global regulatory requirements (e.g. GxP, HIPAA. GDPR, APPI, SOX etc.).
    Strong understanding of ITIL standards.
    Familiarity with the speed and nimbleness of non-GxP systems assurance.
    Excellent attention to detail and documentation.
    Demonstrated ability to work effectively with others, communicate, and influence at multiple levels within multidisciplinary organization.
    Ability to exceed in a non-hierarchal environment.
    Demonstrated ability to manage external service providers and budgets.
    Demonstrated ability to monitor many project release schedules.
    Adeptness in anticipating potential areas of extra focus as identified during the CSIA phase.
    Offer
    A competitive salary package with benefits.
    A work environment in a human-sized, dynamic, rapidly growing biotech company.
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