Karyopharm Therapeutics Inc.

  • Specialist/Sr. Specialist GMP Quality Assurance Operations

    Job Locations US-MA-Newton
    Job ID
    2018-1244
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Overview

    A clinical-stage pharmaceutical company focused on the discovery and development of novel small molecule pharmaceuticals for the treatment of cancer and other major diseases is hiring a GMP Quality Assurance professional.

    Responsibilities

    • Participate in quality oversight of all outsourced operations related to raw material, in-process, and finished good production activities, including warehousing and distribution.
    • Review and evaluate pre-executed and executed Batch Production Records for API, Drug Product, Packaging and Labelling
    • Prepare disposition of clinical and commercial products.
    • Review and approve specifications
    • Review and approve label proofs and packaging customer requests for clinical trials in domestic and international markets.
    • Review and approve packaging components specifications, label proofs and artwork for commercial labeling operations
    • Review non-compliance events that occur during production and testing, collaborate with CMOs and CTOs on investigations and support remediation, as required.
    • Review and approve quality systems in Veeva such as deviations, change control, CAPA,…
    • Assure that source data and information used in regulatory submissions and validation activities is accurate and traceable.
    • Partner with QC to review/approve manufacturing testing data as well as protocols and reports associated with stability, method validation and method transfer, as needed.
    • Support the Quality Management Review.
    • Prepare Annual Product Quality Review.
    • Track QA KPIs and prepare dashboards.
    • Review and approve SOPs
    • Establish/maintain effective relationships with vendors.
    • Ensure quality expectations are being met in the areas of Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and Good Documentation Practice.
    • Participate and contribute to regular meetings held by the Quality organization, and represent Quality at cross-functional meetings and improvement initiatives.

    Qualifications

     

    • B.S. in Life Sciences or related science degree (Chemistry, Biochemistry, etc.) required (an advanced degree in a related field is a plus)
    • 5 -8 years of experience in QA and/or QC within the Pharmaceutical or Biotechnology industry in an operational QA role
    • Experience with manufacturing and packaging/labeling batch record review
    • Experience with data review for accuracy, completeness and compliance
    • 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
    • Understanding of product process and development, from discovery to commercialization is a plus
    • Experience with small molecules and oral dosage forms is a plus
    • Knowledgeable in FDA cGMP regulations, EMA, MHRA, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.

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