Karyopharm Therapeutics Inc.

  • Senior Specialist, GMP Quality Assurance

    Job Locations US-MA-Newton
    Job ID
    2018-1202
    # 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 Senior Specialist, GMP Quality Assurance professional.

    Responsibilities

    RESPONSIBILITIES:

    • Provide quality oversight of all outsourced operations related to raw material, API, Drug Product oral dose, and finished good production activities, including warehousing and distribution.
    • Review and evaluate Batch Production Records for API, Drug Product, Packaging and Labelling to ensure all approved procedures were followed and all specifications were met, proper version control and document integrity, including data generated by different functions, and accordingly approve the final disposition and release of finished product.
    • Track non-compliance events that occur during production and testing, collaborate with CMOs and CTOs on investigations and support remediation, as required. Review and approve internal and CMO QMS records (ie. deviation, CAPA, change control, complaints) in Karyopharm QMS.
    • 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.
    • Review and approve label proofs and packaging customer requests for clinical trials in domestic and international markets.
    • Establish/maintain effective relationships with vendors.
    • Support quality systems, including deviations, change control, CAPA, and continuous improvement.
    • Write, review and approve SOPs and work instructions
    • Assure that source data and information used in regulatory submissions and validation activities is accurate and traceable.
    • Participate and contribute to regular meetings held by the Quality organization and represent Quality at cross-functional meetings and improvement initiatives.
    • Ensure quality expectations are being met in the areas of Good Manufacturing, Good Distribution Practice and Good Documentation Practice.
    • Write and/or review Annual Product Quality Reviews
    • Support CMO/CTO audits as needed
    • Support the Quality Management Review.

    Qualifications

    QUALIFICATIONS:

    • B.S. in Life Sciences or related science degree (Chemistry, Biochemistry, etc.) required (an advanced degree in a related field is a plus)
    • 8-10 years of experience in QA within the Pharmaceutical or Biotechnology industry in a commercial operational QA role
    • Experience with API, solid oral dose and packaging/labeling manufacturing and 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 must
    • Knowledgeable in FDA cGMP regulations, EMA, MHRA, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.

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