Sr. Manager Document Management（GCP, GLP）

1 month ago

Bridgewater, United States Gan & Lee Pharmaceuticals Full time
Job DescriptionJob 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 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 plus

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