Sr. Manager Document Management-GCP, GLP-

Company: Gan & Lee Pharmaceuticals
Location: Bridgewater
Posted on: May 28, 2023

Job Description:

SummaryThis 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 Sr. Manager, Document Management supports all Controlled Document Management at the US Affiliate and Headquarters. -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)
      • 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 plusPowered by JazzHR

Keywords: Gan & Lee Pharmaceuticals, Trenton , Sr. Manager Document Management-GCP, GLP-, Executive , Bridgewater, New Jersey