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1+ months

Lead, Operations QA & Compliance

WIRB-Copernicus Group (WCG)

General Information

Location: Hamilton, NJ

Organization: Analgesic Solutions

Job Type: Full Time - Regular

Description and Requirements

The Lead, Operations QA & Compliance role will establish and maintain quality assurance standards and measures across WCG services organizations and ensuring such standards comply with regulatory requirements and best practice as they relate to Learning Management Systems (LMS).  This position is responsible for working alongside WCG leadership to achieve corporate and departmental compliance goals as well as ensuring the CSO organization remains compliant with the Quality Management System and business processes.

EDUCATON REQUIREMENTS:

       Bachelors degree in a relevant discipline required, or equivalent combination of education and experience.

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:

   Certifications for quality professionals through the Society for Quality Assurance, American Society for Quality or comparable certifications are desirable.

QUALIFICATIONS/EXPERIENCE:


  • Minimum of five (5) years experience in a quality/regulatory compliance position, with a proven track record of success in leading/managing quality assurance projects/assignments, and resources
  • A minimum of three (3) years experience in establishing and monitoring compliance standards across a business unit including analysis and tracking.
  • Prefer a minimum of one (1) year supervising the work of others to complete key initiatives and projects.
  • Possess excellent technical, instructional and collaboration skills. 
  • Thorough knowledge of current regulatory and GCP guidelines as they apply to document management practices in clinical trials and WCG services/products.
  • Strong organizational and planning skills.
  • Strong management skills with a proven record to influence and negotiate.
  • Effective communication (written and oral) skills, organization, and interpersonal skills as well as the ability to interact with WCG personnel, clients, and regulatory agencies as needed.
  • In-depth knowledge and understanding of the clinical trial process.
  • Highly developed problem-solving skills and the ability to resolve difficult conflicts.
  • Ability to work efficiently and independently.

ESSENTIAL DUTIES/RESPONSIBILITIES:

  • To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required.
  • Engage in the continued development, maintenance, and enforcement of the CSO Quality Management System.
    • Manage/lead efforts in the administration, documentation, and reporting of LMS training.
    • Define user roles, create learning courses, and provide feedback to learners as necessary.
    • Provide LMS support during audits and inspections.
    • Establish and enforce quality standards as it relates to records management.
    • Coach and train WCG staff and direct reports on use of LMS.
  • Engage in a professional and efficient collaboration with WCG personnel who author training documents and/or courses for implementation into the LMS. 
    • Develop training curricula based on job titles and roles in collaboration with department heads.
    • Ensure appropriate training is delivered to WCG personnel in a timely manner.
  • Manage the implementation and delivery of WCG required training to WCG personnel, including personnel associated with WCG business acquisitions.
    • Serve as the subject matter expert with respect to the integration procedure for LMS document management processes.
    • Lead the transition of the LMS system for WCG acquisition companies into the WCG framework, as applicable.
    • Manage the implementation and delivery of controlled documents to ensure same is performed in line with industry standards, and regulatory agency regulations and guidance, including but not limited to, GCP.
  • Manage/lead the investigation of LMS system issues and process improvements.
    • Troubleshoot issues reported by personnel.
    • Recognize and resolve issues related to course design and configuration.
    • Communicate and document system issues related to infrastructure for resolution by LMS vendor.
    • Provide LMS vendor with proposals for upgrades to the system to foster process improvements and customer satisfaction.

       Maintain current knowledge with respect to the quality of documents and regulatory compliance best practice.

    • Provide training and guidance to staff regarding compliance and interpretation of regulations.

   Notify personnel of updated document versions and how to access them.

TRAVEL REQUIREMENTS: 20%

Categories

Posted: 2021-05-11 Expires: 2021-06-25

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Lead, Operations QA & Compliance

WIRB-Copernicus Group (WCG)

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