Immunomedics, Inc.

  • Director, GMP Training

    Job Locations US-NJ-Morris Plains
    Posted Date 2 weeks ago(11/28/2018 12:26 PM)
    Job ID
    2018-1376
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    This position is responsible for providing leadership and direction for
    GMP training programs and for ensuring compliance with all relevant FDA
    and EU regulations and guidelines as they pertain to marketed drug
    products. The Director, GMP Training has also responsibility to support
    and identify any suspected deficiencies within the company’s Quality
    Management System.

    Responsibilities

    • Establish and maintain GMP training program to ensure compliance
      to quality systems, current Good Manufacturing Practices (GMPs)
      processes and procedures in support of commercial products
      • Work with functional area departments to Identify training and
      development needs for each GMP area through individual and
      department training curriculum. Provide feedback to team regarding
      training to ensure compliance with SOPs and policies
      • Organize, coordinate, and/or conduct training for GMP personnel
      through classroom (group), one-on-one, LMS web-based training,
      conferences/seminars
      • Maintain the training documentation in a compliant state
      • Coordinate with IT in development, implementation and updates of
      the training materials and programs in the Learning Management
      System (LMS)
      • Represent the site training systems during audits
      • Liaises with corporate team to provide training support and ensure corporate training requirements are met
    • Guide and assist Quality Assurance (QA) programs and activities;
      these include evaluating Training Gaps as they relate to Quality
      Systems and GMP documentation
      • Assist the Relypsa quality team in the development, establishment
      and maintenance of internal Quality Systems Training and
      procedures (e.g., change control, training, audit, CSP management,
      deviation and CAPA) that complies with applicable GMP standards,
      regulations and guidelines
      • Take a proactive role for continuous improvement and lead training
      improvement projects

    Qualifications

    • BA or BS degree in a scientific discipline or equivalent
    • Must have previous experience managing and developing direct reports in a GMP Training function.
    • Must have Bio/Pharmaceutical QA experience.
      • Minimum of eight (10) years of experience in Quality Assurance at an
      operational level supporting manufacturing, quality control in a
      pharmaceutical or biotech environment of increasing responsibilities
      • Prior experience managing and developing direct reports in a GMP
      Training function
      • Prior experience related to managing quality systems in technology
      transfer, scale up and validation
      • In-depth knowledge and full understanding of pharmaceutical GMPs
      (US and EU). Support junior level employees from a GMP knowledge
      perspective
      • Clear understanding of standards of practice used in the
      manufacture of solid dosage forms
      • Experience with effectively supporting FDA inspections. Support EU

    Options

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