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Associate Director, Document Management

Company: Gan & Lee Pharmaceuticals
Location: Bridgewater
Posted on: April 8, 2021

Job Description:

Summary

This position reports to the Sr. Director, Clinical Quality Assurance, Gan & Lee Pharmaceuticals. Regular specific interaction also occurs with the CEO of Gan & Lee Pharmaceuticals USA. The Document Management Associate Director supports all Controlled Document Management at the US Affiliate and Headquarters in China

Education and Credentials

  • College degree in relevant field. Life Sciences Preferred.

    Experience
    • At least 10 years in relevant quality and document management roles in which significant exposure to GCP/GLP has occurred.

      Skills
      • Demonstrated ability to lead people in a positive manner.
      • Demonstrated ability to manage multiple and diverse projects concurrently.
      • Demonstrated ability to develop positive relationships and collaborations.
      • Strong analytical skills; a strategic thinker, planner, and implementer.
      • Reliable, dependable, and consistent worker.
      • Conscientious and extremely detailed oriented.
      • Strong ability to create practical and efficient processes.
      • Highly effective interpersonal skills, in individual as well as in group settings.
      • Strong communication skills (English), both written and verbal.
      • Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

        Responsibilities:

        Document Management:
        • Development and maintenance customer-facing technology documents, user guides, and training materials
        • Oversight and administration of the documentation of SOPs, Work Instructions and Policies
        • Development and maintenance of process maps, external user guides, supporting documents, FAQs and any other documentation needs that arise
        • Interacts with Subject Matter Experts, such as Functional Area Heads and IT as well as end users to ensure documentation thorough and up to date
        • Interacts with IT team to update documentation based on system enhancements and process changes (e.g., eQMS, eTMF)
        • Supports documents creation with Beijing, China team.
        • Manages translation requests with external partner as needs arise
        • Contributes to team effort by accomplishing related results as needed
        • Other duties as assigned.

          Quality Systems:
          • Participate in developing, maintaining and improving of the Quality Management System and associated practices.
          • Participate in inspections performed by FDA and international regulatory agencies; also, audits performed by partners in own area of expertise.
            • Proactively identify analyses and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
            • Perform a gap analysis of existing SOPs and Policies.

              Training:
              • Provide training on SOPs, Policies, Forms and Work Instructions

                Knowledge/Regulation:
                • Review SOPs, Policies, and Work Instructions for compliance with GCP and corporate standards.
                • Provide suggestions for continuous quality improvement in GCP.
                • Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant parts of the Gan & Lee Organization (as applicable)

                  Miscellaneous:
                  • Fluency in Mandarin is a plus
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Keywords: Gan & Lee Pharmaceuticals, Trenton , Associate Director, Document Management, Executive , Bridgewater, New Jersey

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