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Sr. Manager Document Management（GCP, GLP）
Location:
Bridgewater, NJ
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 Powered by JazzHR
Company:
Gan & Lee Pharmaceuticals
Posted:
January 2 on The Resumator
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More About this Listing: Sr. Manager Document Management（GCP, GLP）
Sr. Manager Document Management（GCP, GLP） is a Executive Manager Job at Gan & Lee Pharmaceuticals located in Bridgewater NJ. Find other listings like Sr. Manager Document Management（GCP, GLP） by searching Oodle for Executive Manager Jobs.
Sr. Manager Document Management（GCP, GLP） is a Executive Manager Job at Gan & Lee Pharmaceuticals located in Bridgewater NJ. Find other listings like Sr. Manager Document Management（GCP, GLP） by searching Oodle for Executive Manager Jobs.