Bausch Health

  • QA Commercial (Sample) Compliance Manager

    Job Location US-NJ-Bridgewater
    Job ID
    11125
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • Overview

    QA Manager, Commercial Compliance role is a leadership role responsible for ensuring that Bausch Health Sample Accountability Management Program is compliant with Prescription Drug Marketing Act (PDMA), state regulations and with internal Compliance and Sampling SOPs.

     

    The individual in this role will have overall responsibility for providing Quality oversight  to Bausch Health sample programs, working closely with Sample Operations, Corporate Compliance and third party vendors to ensure compliance in the development and day to day operations of the program

    Responsibilities

    • Provides Quality support to the Sample Operations team responsible for day-to-day front-line field support
    • Serves as a single point of contact and provides guidance on potential sample compliance matters to commercial management, third-party vendors and internal stakeholders
    • Develops and conducts PDMA training for on-boarding and annual refresher training of the Sales Force field personnel and supporting roles and functions
    • Monitors the performance of the program through the conduct of audits of internal operations, Field personnel and external service providers and suppliers
    • Supports Sample Operations, Marketing and Corporate Compliance in the conduct of for cause investigations and enforcement actions
    • Develops and monitors key performance indicators in order to detect gaps and develop process improvement plans
    • Works with Sample Operations in the development of annual process improvement plans

     

    Scope of Position: Quality support of Operations team which supports a team of 2000 Sales Reps

    Qualifications

    • Minimum Bachelors degree
    • Masters preferred

    Experience:

    • 10+ years of experience in pharmaceutical, compliance or life science roles
    • Minimum of 7 years working in a PDMA compliance role
    • English language fluency required

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