Associate Director, Document Management
Company: Gan & Lee Pharmaceuticals
Posted on: April 8, 2021
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
Education and Credentials
- College degree in relevant field. Life Sciences Preferred.
- At least 10 years in relevant quality and document management
roles in which significant exposure to GCP/GLP has occurred.
- Demonstrated ability to lead people in a positive manner.
- Demonstrated ability to manage multiple and diverse projects
- Demonstrated ability to develop positive relationships and
- Strong analytical skills; a strategic thinker, planner, and
- Reliable, dependable, and consistent worker.
- Conscientious and extremely detailed oriented.
- Strong ability to create practical and efficient
- Highly effective interpersonal skills, in individual as well as
in group settings.
- Strong communication skills (English), both written and
- Enthusiastic, genuine, ethical, fair, and loyal to the
organization and its vision and goals.
- 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
- Contributes to team effort by accomplishing related results as
- Other duties as assigned.
- 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
- 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.
- Provide training on SOPs, Policies, Forms and Work
- Review SOPs, Policies, and Work Instructions for compliance
with GCP and corporate standards.
- Provide suggestions for continuous quality improvement in
- 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)
- 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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