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Sr. Manager Document Management（GCP, GLP）
2 months ago
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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