Deerfield Management Companies

  • Director of Quality Assurance

    Job Locations US-PA-Bala Cynwyd
    ID
    2019-1151
    # of Openings
    1
  • Overview

    The role, Director of Quality Assurance, is intended to implement and lead Quality Systems supporting GxP activities, including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) for a virtual company in which contract service providers are used for manufacturing, laboratory testing, clinical studies, etc. This is an exciting opportunity to get involved with a cutting-edge company developing drugs to treat rare mitochondrial diseases.   

    Summary of Position:

    • This position is critical to the successful assurance of quality product manufacturing, clinical data collection, and the proper functioning of GxP systems
    • The position will build on and oversee the existing GxP quality management systems, including establishing quality principles, procedures, audit plan, approach to address non-compliance, etc.
    • This position is responsible for ensuring quality in company GxP activities performed by contractors as well as any internal GxP activities
    • The position will serve as the company’s primary GMP and GDP expert and quality contact for contract manufacturers, and will oversee consultant experts for the company in GCP and GLP activities.
    • As the company grows, the position will be responsible for building out the quality organization and preparing for more complex operations as multiple clinical trials are initiated and multiple projects, at various stages of the development are in the pipeline.

    Qualifications

    • Undergraduate Degree
    • At least 10 years of experience in a cGMP Quality role in the biotechnology industry working with biological manufacturing
    • Thorough understanding of GxP systems and quality principles
    • Demonstrated ability to understand regulations and guidances and translate understanding to practice
    • Demonstrated ability to work with business leads in a collaborative and supportive role

    Chondrial Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

     

     

    Responsibilities

    Job Duties/Responsibilities:

    • Partner with the Chondrial team and third parties to ensure that proper quality standards are set and reliably met
    • Review and approve GxP documentation, including manufacturing batch release packages, deviations and investigations, etc.
    • Oversee the company’s vendor qualification program, including engaging and overseeing external auditors
    • Ensure a Quality System continually compliant with GxPs
    • Build on the existing quality management system and work with the Manager, Regulatory and Quality Operations to maintain the system
    • Ensure internal and external team members are appropriately qualified and trained
    • Work with internal and external team to assist in solving problems and insuring compliance
    • Prepare for and host inspections and audits
    • Approximately 25% travel required

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