Covance Manager, Controlled Documents in Chicago, Illinois

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 withdefined 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

Job Number 2018-23358

Job Category Quality Assurance

Position Type Full-Time

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