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QC Project Lead

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Role: QC Project Lead

Department: Quality Control (QC)

Job Summary

Define and document the project scope, objectives, and desired outcomes related to QC.

Effectively manage projects to ensure all project activities are delivered with high quality and within project timelines.

Responsibilities

  • Act as QC representatives in projects from early product development stage to final commercial production.
  • Work with the CMC team of projects to fully understand the scope of the project and all vital aspects related to QC activities.
  • Build effective partnership with other internal teams to move projects through all phases of the development and commercial stages.
  • Serve as the liaison of QC, maintaining communication with the client and other stakeholders in a project. Build and maintain excellent relationships with clients.
  • Gather and convey project information to the QC team and ensure that all team members understand the scope and deliverables of the project.
  • Prepare and track the schedule of QC activities and ensure that the QC part of the project is carried out on time. Prepare GMP documents, including but not limited to release and stability protocols, in-process sampling and testing protocols, special study protocol per client's requirement, study reports, etc.

Qualifications

  • A Bachelor's degree or higher in a relevant field such as Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, or a related discipline.
  • Bachelor's degree in a related field of expertise is preferred, as well as a minimum of 2 years of experience in project management or similar role.
  • Experience with client management and internal departmental communications.
  • Strong technical background in industry.
  • Strong communication skills in English and Chinese (as this role requires frequent internal collaboration with Chinese-speaking colleagues in HQ), fluent in speaking, writing and reading in both languages.
  • Strong critical thinking, scientific reasoning and problem-solving skills.