Senior Quality Assurance Manager, Legal, Quality,And Compliance
Current
Apr 2024 - Present
AeroLeads people directory · profile
Amy Chen Email & Phone Number
Senior Quality Assurance Manager, Legal Quality and Compliance at Novotech
at
Novotech
1 work email found
@parexel.com
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Senior Quality Assurance Manager, Legal Quality and Compliance at Novotech
Location
Taipei, Taipei City, Taiwan, Province Of China
Company size
Who is Amy Chen? Overview
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Quick answer
Amy Chen is listed as Senior Quality Assurance Manager, Legal Quality and Compliance at Novotech at Novotech, a company with 718 employees, based in Taipei, Taipei City, Taiwan, Province Of China. AeroLeads shows a work email signal at parexel.com and a matched LinkedIn profile for Amy Chen.
Amy Chen previously worked as Senior Quality Assurance Manager, Legal, Quality,and Compliance at Novotech and Quality Assurance Manager, Legal, Quality, and Compliance at Novotech. Amy Chen holds Bachelor'S Degree, Public Health from Taipei Medical University.
Company email context
Email format at Novotech
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{first}.{last}@parexel.com
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Profile bio
About Amy Chen
Dedicated Quality Management for around 12 years experiences in the clinical research industry. Strong competencies, communication and leadership skills, leading worldwide super user teams on both clinical trial technologies knowledge/skill and customer service attitude. Experienced in Quality Management System, Lean six sigma, Clinical Trial Technologies (such as CTMS and eTMF), CAPA process, Risk based monitoring, Training, SOP Development, Business Continuity Plan and Exercise, Sponsor Audits, Regulatory Authority Inspection, and GCP site Audit conduction. Active engaged in 1 EMEA inspection, 3 Taiwan TFDA CRO inspections, more than 20+ Sponsor Audits and 4 GCP site audits.
Listed skills include Microsoft Office, Management, Microsoft Excel, Leadership, and 6 others.
Current workplace
Amy Chen's current company
Company context helps verify the profile and gives searchers a useful next step.
Novotech
8 roles · 22 years
Amy Chen work experience
A career timeline built from the work history available for this profile.
Quality Assurance Manager, Legal, Quality, And Compliance
- Planning, development and management of Novotech’ s Quality Management System (QMS)
- Develop and review of QMS documents
- Leading the Operations team to prepare and facilitate the USFDA, NPRA, and TFDA inspections.
- Planning and hosting of client audits.
- Lead in the investigation and evaluation of quality events (CAPA’s, complaints), incidents and follow-up activities
- Lead and perform internal audits, investigator site audits, perform mock inspections
Jun 2022 - Apr 2024
Quality Manager, Clinical Operations
1. CTMS/ eTMF / PV system and process development and Trainer2. Clinical Operations /Project Management /Risk Based Monitoring related SOP development 3. Quality System Management/ CAPA 4. Perform GCP Site Audits and support Regulatory Inspections5. Business Continuity process development and exercise facilitator
Mar 2020 - May 2022
Contracted Auditor
Freelance, Self-Employed
Perform Due Diligence Audit
Jan 2020 - Feb 2020
Quality Manager, Project Management Qm, Process Optimization And Continuous Improvement
1. Process related support and quality consultant to Project Leaders and Project Specialists worldwide. 2. Supports project deliverable by acting as problem solving consultant, lead RCA and CAPA 3. Look out for opportunities for overall process improvement while managing project specific Quality Issues. 4. Pparticipated in the initiatives for Risk Based.
Feb 2015 - Jul 2019
Quality Manager, System Process And Training, Project Management Qm, Process Qm
1. Served as IMPACT Harmony (Clinical Trial Management System) Process Analyst Lead and IMPACT Harmony Super user coordinator worldwide2. Provided training and established training plans and strategies for Project View (Project Schedule Application) 3. System related SOPs Author4. Served as a quality consultant to operational groups for Technologies. 5..
May 2012 - Jan 2015
Senior Quality Specialist, Process Qm, Project Management Qm, Technologies Support
1. System SME for Clinical Trial Management System and Electronic Document Management System 2. Coordinator for Asia Super User for Clinical Trial Related Systems 3. Clinical Trials Related Systems trainer 4. Served as member of the SOP Technical Review Group.5. Provided input during the development of corporate level quality documents, guidelines and.
Oct 2008 - Apr 2012
Medical Administrator
1. Performed administrator/trainer responsibilities focusing on Clinical Trial Management systems, Journyx Time Recording System, and International Document Management and Electronic Archiving System.2. Set up the local Document Management Archiving System3. Developed local Working Instruction4. Event Planner for all Clinical Trial Investigator meetings5..
2004 - Sep 2008
Team & coworkers
Colleagues at Novotech
Other employees you can reach at novotech-cro.com. View company contacts for 718 employees →
SR
Shri Raksha
Colleague at Novotech
Bengaluru, Karnataka, India, India
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MK
Myeongsu Kim
Colleague at Novotech
Seoul, South Korea, Korea, Republic Of
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AV
Alma Veronica Vargas Valencia
Colleague at Novotech
Randwick, New South Wales, Australia, Australia
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MS
Manana Shatirishvili
Colleague at Novotech
Georgia, Georgia
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VS
Varun Subramanya
Colleague at Novotech
Bengaluru, Karnataka, India, India
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SK
Shania Ks
Colleague at Novotech
Bengaluru, Karnataka, India, India
View →
PB
Prachi Bulbule
Colleague at Novotech
Pune, Maharashtra, India, India
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RS
Ruchi Sheth
Colleague at Novotech
Pune, Maharashtra, India, India
View →
JV
Jeisson Velásquez Valbuena
Colleague at Novotech
Tocancipa, Cundinamarca, Colombia, Colombia
View →
HO
Han Oakpil
Colleague at Novotech
South Korea, Korea, Republic Of
View →
Shri Raksha
Colleague at Novotech
Bengaluru, Karnataka, India, India
View →
MK
Myeongsu Kim
Colleague at Novotech
Seoul, South Korea, Korea, Republic Of
View →
AV
Alma Veronica Vargas Valencia
Colleague at Novotech
Randwick, New South Wales, Australia, Australia
View →
MS
Manana Shatirishvili
Colleague at Novotech
Georgia, Georgia
View →
VS
Varun Subramanya
Colleague at Novotech
Bengaluru, Karnataka, India, India
View →
SK
Shania Ks
Colleague at Novotech
Bengaluru, Karnataka, India, India
View →
PB
Prachi Bulbule
Colleague at Novotech
Pune, Maharashtra, India, India
View →
RS
Ruchi Sheth
Colleague at Novotech
Pune, Maharashtra, India, India
View →
JV
Jeisson Velásquez Valbuena
Colleague at Novotech
Tocancipa, Cundinamarca, Colombia, Colombia
View →
HO
Han Oakpil
Colleague at Novotech
South Korea, Korea, Republic Of
View →
4 education records
Amy Chen education
Bachelor'S Degree, Public Health
Applied Economics
Henry George School Of Social New York
Fundamental Economics
Henry George School Of Social Science, New York
Esol
Lenox Hill Neighborhood House New York
FAQ
Frequently asked questions about Amy Chen
Quick answers generated from the profile data available on this page.
What company does Amy Chen work for?
Amy Chen works for Novotech.
What is Amy Chen's role at Novotech?
Amy Chen is listed as Senior Quality Assurance Manager, Legal Quality and Compliance at Novotech at Novotech.
What is Amy Chen's email address?
AeroLeads has found 1 work email signal at @parexel.com for Amy Chen at Novotech.
Where is Amy Chen based?
Amy Chen is based in Taipei, Taipei City, Taiwan, Province Of China while working with Novotech.
What companies has Amy Chen worked for?
Amy Chen has worked for Novotech, A2 Healthcare Taiwan Corporation, Freelance, Self-Employed, Parexel, and Boehringer Ingelheim.
Who are Amy Chen's colleagues at Novotech?
Amy Chen's colleagues at Novotech include Shri Raksha, Myeongsu Kim, Alma Veronica Vargas Valencia, Manana Shatirishvili, and Varun Subramanya.
How can I contact Amy Chen?
You can use AeroLeads to view verified contact signals for Amy Chen at Novotech, including work email, phone, and LinkedIn data when available.
What schools did Amy Chen attend?
Amy Chen holds Bachelor'S Degree, Public Health from Taipei Medical University.
What skills is Amy Chen known for?
Amy Chen is listed with skills including Microsoft Office, Management, Microsoft Excel, Leadership, Microsoft Word, Powerpoint, Research, and Training.
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