
Xuefei Zhou
•Over 14 years of experience in the pharmaceutical and biotechnological and medical device industries, crossing all functional areas... | Mahwah, New Jersey, United States
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Xuefei Zhou’s Emails zh****@wu****.com
Xuefei Zhou’s Phone Numbers No phone number available.
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Xuefei Zhou’s Location Mahwah, New Jersey, United States
Xuefei Zhou’s Expertise •Over 14 years of experience in the pharmaceutical and biotechnological and medical device industries, crossing all functional areas including Quality Insurance, Manufacturing support, Technology and Research and Development •In depth knowledge of cGMP/GLP/GCP and regulatory requirements from FDA, EMA and ICH, and ability to apply them in the applicable quality disciplines to ensure quality and sustainable compliance •Strong leadership ability, proficiency in project management and the ability to focus and drive project to successful completion. Lead a group of professionals in the validation and subsequent regulatory filing of a new vaccine ensured the highest quality and compliance as demonstrated by favorable outcomes from inspections and audits by global regulatory bodies including FDA, EMA, Japan, Korean FDA, etc. •Highly experienced and skilled in dealing with regulatory inspections, third party audits •Strong interpersonal, communication and management skills •Extensive knowledge and experience in the validation of manufacturing processes, clean room/environmental qualification, pharmaceutical cleaning processes, water and steam systems and facilities •Computer skills in Microsoft Word and Access, familiar with enterprise systems, SAP SCC and CAPA •Manage a Database tracking all documents reviewed by the entire QAV group
Xuefei Zhou’s Current Industry Acceledev
Xuefei
Zhou’s Prior Industry
Dept Of Mechanics And Materials Science Rutgers University
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Howmedica Inc Pfizer Medical Technology
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Howmedica Pfizer
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Purepac Pharmaceutical
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Pfizer
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Protein Sciences
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Beyondspring
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Matrivax
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Cartesian Therapeutics
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Wuxi Biologics
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Acceledev
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Work Experience

Acceledev
Head of Quality, Acceledev
Sat Jul 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Wuxi Biologics
Site QA Head, Wuxi Biologics, Cranbury, New Jersey
Mon Mar 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jul 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Cartesian Therapeutics
Senior Director, Quality Operations
Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Feb 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Matrivax
Vice President, Quality Operations
Mon Jul 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Beyondspring
Vice President Quality Assurance
Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jul 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Protein Sciences
Senior Director, Quality Operations
Thu Dec 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Dec 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Protein Sciences
Director Quality Assurance
Sat Nov 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Pfizer
Manager
Mon Apr 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Nov 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Purepac Pharmaceutical
Validation Engineer
Mon Oct 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time)
Howmedica Pfizer
Engineer/Supervisor
Mon Jun 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Mar 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time)
Howmedica Inc Pfizer Medical Technology
Engineer/supervisor
Wed Jan 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time)
Dept Of Mechanics And Materials Science Rutgers University
Research Assistant
Fri Jan 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 1990 00:00:00 GMT+0000 (Coordinated Universal Time)