Karyopharm Therapeutics Inc.

  • Vice President of Quality

    Job Locations US-MA-Newton
    Job ID
    2018-1233
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

     

    Karyopharm Therapeutics is actively seeking a Vice President of Quality to join our rapidly growing organization in Newton, Ma. The incumbent will establish the vision for the Quality Group, lead the company’s global Quality strategy and ensure compliance with GXP requirements. The ideal candidate will be a strategist with the capability to manage the day to day operation of the department and oversee the company’s inspection readiness initiatives. Additionally the Vice President of Quality must have the skills and experience to meet the challenges, responsibilities and rewards that come from working in a high energy fast paced environment.

    Responsibilities

    • As a senior leader of the organization, develop short and long range quality plans and strategies that support Karyopharm investigational products.
    • Provide leadership and guidance to the organization regarding quality, training and inspection readiness.
    • Analyze and make recommendations for improving QA systems as well improving vendor compliance with FDA, international regulatory authorities and ICH regulations and guidelines
    • Develop and implement strategies for the timely preparation and execution of quality submissions to regulatory authorities for all phases of the product life cycle
    • Lead the global quality organization to ensure compliance with GXP requirements
    • Create a quality organization and system that will provide Karyopharm with a competitive advantage in the market place
    • Ensure Karyopharm is in compliance through policies, standards and audit systems
    • Establish the proper environment to ensure that there is a quality focus in all activities of the business
    • Direct the QA auditing program which includes assessing outside contractors, conducting internal and external quality audits and managing regulatory inspections
    • Review and evaluate complaint records and investigation process for complaints
    • Enhance product quality documentation system
    • Manage budgets, control cost and analyze variances
    • Oversee company-wide training compliance for all of quality
    • Actively engage in appropriate activities to influence and the meet the changing needs of the regulatory environment through QA and other venues.
    • Provide guidance and support for Quality Management Review.

    Qualifications

    • Advanced degree in scientific discipline with equivalent experience and training
    • 10+ years of experience with progressively increasing responsibilities in quality within the pharmaceutical or biotech industries
    • Advanced working knowledge of eGCP required
    • Expert in US FDA EU and GMP regulations in required
    • 10+ years of management experience required in QA and QC functions
    • Knowledge and understanding of global regulations and guidelines’
    • Proven management and leadership experience, including identification and development of talent
    • Excellent communication skills required.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed