Wendy Chen
Clinical CMO Quality Manager @ Biogen | Quality Management
- Role
- Clinical CMO Quality Manager at Biogen
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Wendy Chen
With close to ten years of experience in quality management and operations in the biotechnology industry, I am passionate about ensuring compliance, efficiency, and excellence in clinical manufacturing. I have a MBA in Data Analytics, a Graduate Certificate in Regulatory Affairs, and a Certificate in Full Stack Web Development, which enable me to leverage data, technology, and innovation to solve complex problems and improve quality outcomes. As a Clinical CMO Quality Manager at Biogen, I align my values and goals with the company\'s mission to discover, develop, and deliver worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.In my current role, I am accountable for managing the clinical quality operation activities with key and critical CMOs, ensuring that they maintain quality systems that are in compliance and aligned with Biogen expectations. I have participated in the technology transfer, scale-up, and improvement projects through validation and on-site presence, and identified and communicated any supply risk or batch rejection to management. I have also prepared and managed Quality Management Review and Quality Agreements with CMOs, and solved technical and operational problems in API/DS, DP, and FGI manufacturing. I have applied my Lean Six Sigma skills to identify and drive opportunities for improvement and standardization in the process. I have also supported internal and external audits, reviewed and approved cGMP documentation, and executed intermediate technical writing and investigation support.
Experience
Clinical CMO Quality Manager
Sep 2021 — Present · NC, US
Accountable for management of Clinical Quality operation activities with key and critical CMOs- Ensure CMOs maintain quality systems that are in the state of compliance and aligned with Biogen expectations- Participated in the technology transfer, scale-up, and improvement projects through validation and on-site presence- Identify and timely communicate to management any supply risk or risk of batch rejection- Prepare and manage Quality Management Review and Quality Agreements with CMOs- Solve technical and operational problems in API/DS, DP, and FGI manufacturing by utilizing existing procedures, solutions, and policies- Identify any drive opportunities of improvement and standardization in the purpose of continuous improvement of the systems and processes used- Support the timely disposition of clinical batches to support clinical trials and prevent stock outs- Support the GDCCS (Global Distribution Cold Chain Solution) team as the Quality contact for review and approval of all DQ, OQ, PQ reports and protocols to evaluate and establish approved and compliant shipping lanes for all Biogen products (Clinical and Commercial Cell Banking, API/DS, DP, FGI, FG, QC Samples).
Education
The University of North Carolina at Chapel Hill
Certificate, Full Stack Web Development
2019 — 2019
Massachusetts College of Pharmacy and Health Sciences
Graduate Certificate, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
2016 — 2017
University of Massachusetts Amherst
Bachelor of Science, Public Health
2008 — 2013
The University of North Carolina at Pembroke
Master of Business Administration - MBA, Data Analytics
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