Covance

  • Manager, Controlled Documents

    Job Location(s) US-NJ-Princeton | US-NC-Raleigh-Durham | US-MA-Boston | US-TX-Dallas | US-IL-Chicago | US-CA-San Diego
    Job Number
    2018-23358
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    The preferred location for this position is office based in Princeton, NJ, but the role can also be home based anywhere in the United States. 

     

    • Controlled Document Development, Processes, and Systems
        • Conduct quality reviews of proposed draft Controlled Documents (CDs) for consistency and compliance with established or pending CDs, corporate or CDS policies and regulatory standards
    • Collaborate with identified functional area Subject Matter Experts (SMEs) to develop and review CDs, based on existing or new internal processes
    • Serve as SME expert for clinical SOPs on cross-functional teams
      • Independently, coordinate and lead meetings with SME’s and stakeholders, including conducting concise interviews with internal staff and stakeholders, as needed, to gather required information to create CDs
      • Ensure documentation and supporting communication processes are reviewed and approved by appropriate stakeholders.
      • Assist Standards management with:
        • Administration and ongoing continuous improvement of the CDS system and processes
        • Monitoring internal and external notifications of changes to regulations or business processes and where necessary, proactively facilitate the initiation/revision of company procedures
        • The development and establishment of processes to maintain currency and accuracy of best practices relating to the development, revision and management of CDS
      • Develop and conduct training sessions on CDs and related practices (e.g., SOP development and management processes)
      • With guidance, employ change management philosophies during development and implementation of CDs
      • Effectively manage CDs, through planning, development, review and publication
      • Participate in and/or lead RCQA/Standards process improvement initiatives
      • Develop and maintain tracking documents to support CDS compliance with defined CD review timelines and CAPA commitments
      • Maintain electronic distribution and hard copy master file for current and historical CD development and approval
      • Continuously maintain a central repository for internal CDs (e.g., CD SharePoint portal)
      • Facilitates the training of CDS staff on CDs within the iLearn system, including conduct training sessions on the QA System and Controlled Document/SOP system
      • Ensure secure and controlled provision of CDs to external recipients (e.g., auditors, inspectors)
    • Leadership/Management
      • Contribute to the creation and implementation of training and development of Standards staff
      • Supports global inspection readiness, client audits, and regulatory inspections, as needed
      • Represents RCQA on project teams and other internal forums
      • Provide CD related support for regulatory inspections, client audits, third party SOP requests, and distribution of non-CDS controlled documents (e.g., client SOPs)

    Education/Qualifications

    • University/college degree (BA/BS – life science preferred) OR Associate degree AND five (5) years’ experience in the pharmaceutical / CRO industry
    • Thorough knowledge of ICH GCP, including international regulatory requirements for the conduct of clinical development programs

    Experience

    • Minimum, five (5) years’ experience in the pharmaceutical/Contract Research Organization (CRO) industry, preferably with three (3) year within a GCP environment
    • Strong analytical skills
    • Excellent communication (i.e., oral, written and presentation), interpersonal, planning and organizational skills
    • Ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
    • Ability to inspire effective teamwork and motivate staff within a matrix system
    • Skilled in successfully leading cross-functional working groups, independently
    • Demonstrated ability to support multiple competing priorities across clinical operating units
    • Demonstrated ability to influence effectively and implement change in complex matrix organizations
    • Support the Standards management in leading a global team

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