Karyopharm Therapeutics Inc.

  • Associate Director, GMP Quality Assurance (QA)

    Job Locations US-MA-Newton
    Job ID
    2018-1239
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company, based in Newton, MA, USA, focused on the discovery, development and commercialization of novel, first-in-class agents targeting nuclear transport for the treatment of cancer and other major diseases. Karyopharm is the industry leader in oral Selective Inhibitor of Nuclear Export (SINE) technology, developed to address a central mechanism of oncogenesis via the inhibition of exportins specifically XPO1. Selinexor, Karyopharm’s lead candidate, has been administered to patients with hematologic malignancies or solid tumors in clinical trials worldwide. Karyopharm is currently preparing for its first potential U.S. commercial launch in 2019.

     

     

    Responsibilities

    The Associate Director of Quality Assurance will:  Provide strategic and operational leadership for the quality oversight of both drug substance and drug product manufacturing, packaging, labeling and distribution.  Support Quality Management Systems within GMP operations to ensure phase appropriate quality systems are used throughout the lifecycle of the products.  Manage activities and projects to meet company objectives through manufacturing and product development, including review, approval and QA oversight of all aspects of: clinical and commercial manufacturing at CDMOs, packaging and labeling, warehousing and the global distribution of clinical and commercial API and Drug Product. Responsible for ensuring all company, regional, and global standards and regulations are met, and that the department is developed and maintained to a standard that ensures the quality of products and materials produced by our contracted partners.  Responsible for implementation and sustainment of commercial quality systems.

    • Provide quality oversight of all raw material, in-process, and final product production activities, including warehousing and distribution. Participate in regular meetings with CDMOs and CTLs.
    • Review and evaluate Batch Production and QC Control Records for API and Drug Product data to ensure all approved procedures were followed and all specifications were met.
    • Support and /or approve product disposition.
    • Provide QA support for non-compliance events e.g deviations, OOS, investigations, etc. that occur during production and testing, investigate and support remediation.
    • Provide QA review and approval for Quality System e.g change controls, CAPA, quality product complaints, etc.
    • Participates on withdrawal and recall teams.
    • Provide quality oversite and support of labeling documentation. Ensure proper version control and document integrity of packaging component labeling, specifications, printed labeling artworks, etc.
    • Participates efforts to establish control strategies for manufacture processes to help ensure process understanding and product quality targets.
    • Ensure Karyopharm’s quality expectations are being met in the areas of Good Manufacturing Practice, Good Distribution Practice and Good Documentation Practice.
    • Partner with QC function to provide QA oversite of documents associated with stability, method qualification / validation, method transfer, etc.
    • Write, review and/or approve SOPs for QA clinical and commercial systems e.g. recalls, Field alerts, complaints, annual product review,…
    • Review and approve SOPs related to QC and supply chain clinical and commercial operations e.g. artwork management, method validation/qualification/transfer,
    • Assure that source data and information used in regulatory submissions and validation activities is maintained and traceable.
    • Support Quality Management Reviews.
    • Propose quality improvements to maintain compliance and improve efficiency as part of continuous improvement initiatives.
    • Support Annual Product Quality Reviews.
    • Lead, coach, train and mentor staff in support of their professional and career development.
    • Participate and contribute to regular meetings held by the Quality organization, and represent Karyopharm Quality at cross-functional meetings and improvement initiatives.
    • Travel may be required up to 15%

    Qualifications

    • B.S. in Life Sciences or related science degree (Chemistry, Biochemistry, etc.) required (an advanced degree in a related field is a plus).
    • Minimum (10) years of experience within the Pharmaceutical or Biotechnology industry in a quality role. QC experience is a plus.
    • Experience with the CMC and Regulatory Filing requirements.
    • Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations.
    • Good understanding of product process and development, from discovery to commercialization.
    • Experience with small molecules and oral dosage forms is highly preferred.
    • Knowledgeable in FDA cGMP regulations, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.
    • Experience in managing, hosting or supporting FDA, EMA or other regulatory agency inspections.

     

     

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