Halo Pharmaceuticals

  • Quality Assurance Compliance Training Manager

    Job Location US-NJ-Whippany
    Type
    Regular Full-Time
  • Overview

    The Quality Assurance Compliance Training Manager is responsible for managing the Training Department, overseeing development and administration of TMS training curricula that provide comprehensive training to employees, and assures training compliance. This position will also promote compliance and a continuous improvement culture to drive process and cost improvement. This position will interact with departments within Halo to critically evaluate quality systems in order to support process improvements.

    Responsibilities

    • Monitors evolving regulations, standards and governmental agency activities, interprets relevant information and takes appropriate actions to inform and educate stakeholders and revise the Procedures, as necessary.
    • Manages the Compliance and Training Department to ensure adequate training related to the TMS and production of conforming product.
    • Work with Human Resources and Hiring Managers to establish and maintain a supportive on-boarding program for new hires and transfers.
    • Staff, train and supervise a group of professionals to discharge duties as necessary to assure effective company compliance with pharmaceutical and quality system regulations relating to Training and Compliance functions.
    • Conducts “Train the Trainer” training to develop trainers for effective administration of training curriculum.
    • Responsible for oversight and control of training records.
    • Work with department managers to improve training programs and training comprehension.
    • Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and appropriate regulations.
    • Provide support during regulatory inspections and client audits as applicable
    • Provides inspection readiness support to the site -identification of compliance gaps and risks, and participation in the remediation process.
    • Participate in inspection preparation, and participate in regulatory inspections, defending Deviation/CAPA policies and practices.
    • Ensure a proactive determination of regulatory, compliance and quality issues and integrates them into audits/assessments on a priority basis.
    • Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
    • Review and approve Master Batch Records /Validation Protocols and reports
    • Review Annual Product Reviews
    • Manage product complaints for commercial and clinical investigational product
    • Analyzes, implements, adapts, conducts, and evaluates training materials, training courses, and overall training programs related to subject matter areas/topics.
    • Assesses the quality and effectiveness of training programs for continuous improvement
    • Responsible for data collection for training metrics.
    • Assist in meeting departmental goals, and special projects as needed.
    • Perform other related duties as required.

    Qualifications

    • Experience in training trainers
    • Knowledge of curriculum design (classroom).
    • Demonstrated ability to select, organize, lead, participate and facilitate a team to produce results.
    • Ability to multi-task, and handle a number of projects simultaneously in a fast paced environment.
    • Proficient in the use of MS Office applications (Excel, Word, Powerpoint) is required.
    • Communication (Oral/Written) – Ability to communicate effectively in oral and written form.
    • Problem Solving – Ability to find a solution or deal proactively with work related problems. Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices. Strong problem solving skills and analytical assessment for continuous improvement.
    • Interpersonal – Ability to develop and sustain positive relationships with internal as well as external customers.
    • Confidentiality – Ability to work with and keep sensitive information confidential
    • Ability to move about the facility
    • May spend periods of time in front of a computer

     

    EDUCATION:  

    • Bachelor’s Degree (BA or BS) in Education, Communication, or related discipline plus a minimum of five years’ training experience or a Masters Degree plus a minimum of three years training experience.

     

    EXPERIENCE:

    • 5+ years related experience and/or training
    • Experience in training in a pharmaceutical company preferred

     

     

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