Immunomedics, Inc.

  • GMP Training Manager

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(4/17/2019 2:19 PM)
    Job ID
    2019-1437
    # of Openings
    1
    Category
    Quality
  • Overview

    The GMP Training Manager is responsible for ensuring that the training and qualifications systems are in place to assure that personnel are trained, qualified and competent to perform their assigned job functions in accordance with regulatory requirements and IMMU Policies and Procedures.

    Responsibilities

    • Develop, implement and maintain a Training System that ensures IMMU personnel are trained, qualified and competent to perform the assigned job functions at the Site level.
    • Oversee and maintain Learning Management System (Compliance Wire).
    • Maintain and assure compliance with IMMU Training Policies and Procedures.
    • Create and deliver training using innovative and traditional techniques to ensure personnel are engaged and effectively qualified in their roles.
      • Embed the “WHYS” into site-specific training and procedures to ensure employees understand their role and the rationale behind performing specific tasks.
    • Continually assess the performance of the Training Department to ensure continuing compliance and streamline the department with a focus on efficiencies.
    • Partner with other departments to develop training strategies and support them in the development of employee training curricula, qualification programs and associated materials.
    • Develop, communicate and implement the Site Master Training Plan.
    • Maintain a cGMP training program for all newly hired personnel.
    • Drive efforts for the development and implementation of an annual cGMP Awareness Training Program for all GxP employees. Assure compliance with minimum training requirements.
    • Ensure that trainers are qualified and support the “Train the Trainer” program.
    • Develop and present Training Metrics to the Site Quality Council.
    • Participate in internal cGMP, Corporate or Regulatory agencies’ audits and inspections (i.e. FDA, etc.).
    • Operate all related activities within budget guidelines.

    Qualifications

    • Bachelor’s Degree.
    • At least 5 years of experience in a biotech/pharmaceutical industry.
    • 3-5 years of practical experience in compliance Training and Qualifications matters.
    • 3-5 years of particle management of exempt and non-exempt administrative personnel.
    • Practical Learning Management Systems (LMS) Exprience
    • Demonstrated ability to remain flexible and adaptable to frequent change.
    • Excellent problem solving, written, and verbal communication skills.
    • Superior attention to detail, organizational skills, and the ability to handle multiple tasks concurrently in a timeline-driven environment.
    • Ability to successfully communicate with all stakeholders based upon their technical understanding.
    • Self-motivated, with the ability to work effectively in a dynamic and geographically diverse environment.
    • Must be proficient with MS Office applications.
    • Experience working in a regulated environment, ideally biotech/pharmaceutical, is strongly preferred.

     

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