YEN MY HUYNH-WONG

Cell No.: 408-***-**** E-mail: adjyv5@r.postjobfree.com

Yen My Huynh-Wong Curriculum Vitae Page 1 of 5

PROFILE

Bachelor of Arts (B.A.) in Biological Science, Minor in Business, and Master of Business Administration (M.B.A) with over 20 years of experience in Quality, Project Management, Research & Development (RD). SUMMARY

Over 20 years of combined experience in the Biotechnology/Pharmaceutical (Bio-Pharma), Eye Healthcare, Medical Device/Diagnostics industry encompassing Commercial Quality Assurance (QA) and Research and Development (R&D).

Over 18 years experience in bio-pharma working in a Quality (Commercial, Operations, Systems) role.

Over 5 years experience of product/project management experience in collaboration with diverse functional departments and CxO.

Over 4 years experience in medical device/diagnostics working in a Clinical and R&D role.

Proven leader/mentor – managed, developed, and promoted subordinates.

Experience with design, implementation, and management of paper based, hybrid-based document/electronic, archival and electronic document management system, and proactively led continuous improvement cross- functionally.

Experienced with leading work streams for implementation of an Electronic Document Management System

(EDMS). Played a pivotial role in performing data migration, System Suitability Testing (SST)/ User Acceptance Testing (UAT), pre/post implementation activities for Veeva Vault platform.

Effective trainer and communicator that performs with thoroughness and efficiency for promoting “Right First Time”.

Collaborative team member whose strengths encompass diligence, ability to acclimate to change, effective multi-tasking skills, detail-oriented, with exceptional organization and prioritization, and understands and executes as per GDP and cGMPs.

Exemplary interpersonal skills with proven demonstration through consistent accountability, excellence, inclusion, integrity, and teamwork. Recipient of 38 Gilead awards (26 GThanks Awards, 2 Key Contributor Awards, and 10 Values At Work Awards).

EXPERIENCE

CONFIDENTIAL BIOPHARMACEUTICAL COMPANY March 2020 – Present Quality Systems

Implementation Lead and Quality Management Systems (QMS) Business Owner for the management of the electronic QMS (eQMS: Deviation, CAPA, Change Control, Complaints, Internal & External and Supplier Quality Audit work streams) and promote cross-functional engagement to drive continuous of company quality processes.

Generate Quality System metrics and reporting for Quality Council and Quality Systems Review Board

Provide instructor led training and support for Veeva Vault QualityDocs and Quality Management System

(Deviation, CAPA, Change Control, Complaints work streams)

Author, review, edit, format Standard Operating Procedures & Work Instructions, and create training slides and videos for end users of Veeva Vault QualityDocs (QDocs) and Quality Management System (QMS).

Manage eQMS training curricula and with IT collaboration support timely turn-around of granting users access.

Support Internal and Supplier Quality program management

Implementation Lead for Inspection Management tool

Proven track record of successful, on-time implementation of 5 Veeva Vault work streams within 10 months of tenure; implementation lead of three additional work streams with a tentative business go-live mid May 2021.

Recipient of 3 awards during 10 month tenure for demonstrating excellence for cross-functional support. Cell No.: 408-***-**** E-mail: adjyv5@r.postjobfree.com Yen My Huynh-Wong Curriculum Vitae Page 2 of 5

GILEAD SCIENCES, INC., Foster City, CA May 2008 – March 2020 QA Team Lead

February 2016 – March 2020

Managed (5), supervised, and mentored (10) QA Documentation personnel including organizing and prioritizing workflow, daily tasks following defined processes/procedures. Identified, and implemented process improvements, develop, and deliver training as needed.

Created, maintained and contributed to continuous improvement of document templates. Wrote and revised Standard Operating Procedures (SOPs) and Work Instructions (WI) for continuous improvement of systems.

Developed and delivered training relating to document control processes, templates and systems as required to Document Control staff and users.

Led data migration work streams, participated in configuration workshops, performed system suitability testing

(SST), dry run for UAT for implementation, and provided enhancement requests for Veeva Vault Quality Document Management System (QDMS)

Provided system administrative support related to Electronic Document Management System (EDMS) and other systems as required, including troubleshooting systems. Identified opportunities for process improvement and works with staff to implement changes.

Provided training on issues affecting own area of work to Quality Assurance Document Control (QADC) personnel as required. Notified manager of compliance questions, issues, investigated and initiated deviations as needed.

Provided supported (Library/Scribe) to internal and regulatory audits/inspections as required.

Supported the development, implementation, and continuous improvements, conduct Owner/Author, Reviewer/Approver, support DocSteward, and DocCoordinator Instructor Led Courses (ILC), and role approval through Identity Management (IDM) System for Veeva Vault QDMS.

Supported WalkMe, Digital Adoption Platform (DAP) Project by data mining for recurrence of issues reported by users of Veeva Vault QDMS.

Trainer for on-boarding DCs and Embedded Document Coordinator (EDC) in QA Document Control (QADC) and creates presentations and establish training for EDCs QA Documentation Specialist II

May 2014 – January 2015

Performed administration of the Electronic Quality Management System (EQMS) in support of GxP documentation.

Provided support to customers with documentation issues word processing. Assist with the correct and timely implementation of CRs and Documents.

Analyzed CRs for completeness. Communicates with customers to ensure changes are concise and complete.

Assisted with periodic review processes and ensure the correct and timely input of database entries pertaining to period reviews performed in EQMS

Authored/investigated, initiated, and managed Problem Records (PR)/Deviations and Corrective Action Preventive Action (CAPA), CAPA Effectiveness Checks, on behalf of other document coordinators as needed.

Created and revised SOPs and WIs for continuous improvement of documentation systems.

Developed training materials for document control, mentor and train document coordinators as needed.

Identified areas for improvements, and proposed changes to management (Operational Excellence).

Interacted with appropriate departments to establish priorities and deadlines for processing CR and documents.

Provided support to internal and regulatory audits/inspections as required. Cell No.: 408-***-**** E-mail: adjyv5@r.postjobfree.com Yen My Huynh-Wong Curriculum Vitae Page 3 of 5

QA Specialist II

April 2009 – May 2014

Assisted with process validations and batch record qualification of Active Pharmaceutical Ingredient (API) and Spray-Dried Dispersion (SDD).

Authored annual quality reviews, validation reports, and assisted with regulatory filings.

Conducted or served as a lead/coordinator of complaint investigations and corrective and preventive action

(CAPA) recommendations related to manufactured products.

Developed work instructions regarding disposition process of Commercial API and serve as Subject Matter Expert (SME) for Integrated Quality System (IQS) training for new employees.

Ensured the Commercial API and SDD (Cardiovascular, HCV, HIV, and Pulmonary) supplies are released in compliance with cGMPs, Gilead SOPs and regulatory filing requirements.

Evaluated deviations, Out Of Specification (OOS)/Out Of Tolerance (OOT) and investigations for compliance and impact on product quality.

Interfaced with API and SDD contractors to address quality, documentation and compliance issues.

Reviewed manufacturing batch records and assist in the review of master batch record changes for commercial Cardiovascular, HCV, HIV, and Pulmonary APIs and SDD.

Supported implementation of the integration with QA systems and ensured alignment and consistency between Gilead Palo Alto and Foster City.

Supported inspection readiness and performed as Librarian for 2 successful inspections (FDA and IMB). Associate, Quality Assurance

May 2008 – April 2009 (Formerly: CV Therapeutics, Inc.)

Implemented and maintained Document Control metrics.

Maintained Quality Systems databases (Change Control and Deviations); and follow-up on deviations and change controls close out.

Performed document control functions including the initiation of workflow packages, review, approval, distribution and maintenance of the Document Control process for cGxP documentation through EDMS

(Documentum).

Performed record audits of Change Control (CC), Deviations and Destruction Authorization Forms (DAFs).

Performed Sub-Admin responsibilities for the Learning Management Systems (ComplianceWire) for managing GXP training.

Responded to inquiries from internal customers and distribute controlled documents to CMOs.

Revised SOPs and worked with initiators to ensure compliance with procedures.

Set up and maintain hard copy GxP documents/records and coordinate off-site storage.

Supported EDMS validation activities (Execute OPQ, document discrepancies and verify data migration) and train users on EDMS.

GENENTECH, INC., San Diego, CA November 2005 - December 2007 Technology Transfer Team Member QADC Lead

August 2007 – December 2007

Established quality results under an aggressive timeline. Played a pivotal role in successful early completion of technology transfer by tracking, controlling, and reporting progress against the plan to Core Genentech Technology Transfer Team Members.

Implemented a strategy and plan, project managed, led, and executed transition of technology from the San Diego to South San Francisco facility.

QA Document Control Team Lead

Quality Assurance Associate II

November 2005 – August 2007 (Formerly: Tanox West, Inc.)

Assisted in the creation and editing of controlled documents as needed. Cell No.: 408-***-**** E-mail: adjyv5@r.postjobfree.com Yen My Huynh-Wong Curriculum Vitae Page 4 of 5

Wrote training plans for new employees within QADC and SME for QADC department.

Managed and streamlined the document change control and archive system; including review of document change controls for content and clarity, issuance and control of all batch record stages and production related logbooks. Processed approximately 380 document change requests within 2 months.

Supported internal audits and performed GMP facility inspection and release.

Performed batch record review, approval, and release of Phase II API and Drug Product for clinical use.

Conducted raw material review and approval of approximately 280 incoming raw material lots within first year per general chemical analysis testing methods, for accuracy, completeness, and compliance with cGMP documentation standards.

Provided critical inspection support during regulatory inspections. CALYPTE BIOMEDICAL CORP., Alameda, CA June 2002 - June 2004 Quality Assurance - Document Control

Modified quality documents in Microsoft Word and implement Change Control/Update of documents. Generated and revised Component Specification Forms (CSFs), Device History Records (DHRs), SOPs, and Material Safety Data Sheets (MSDS).

Performed Label Production and control, with 100% inspection, review and approval. Data entry, analysis trending and coordinating technical services for QC and Manufacturing.

Reviewed and released CSFs per general chemical analysis testing methods for accuracy and completeness in accordance to cGMP.

NASA AMES RESEARCH CENTER, Moffett Field, CA July 2002 - April 2003 Research Assistant I (Structural Systems and Biomineralization Lab) – Education Associates (EA) Intern

Conducted Quantitative Bone Histomorphometry on tibular fibular junction of wild type and transgenic mice for Hindlimb Unloading (HU model) study.

Performed Statistical Analyses on mice data, wrote as well as updated procedures or protocols for experimental machinery.

Processed bone mass, ash and calcium weights and measurements of mice. Collected Fluorochrome-based data from unstained bone sections under UV illumination by use of Microscopy (Nikon Microscope). Used NIH Image program for digitized images and calculations of mice tibiofibular junction of bone sections. INCYTE GENOMICS, CORP., Palo Alto, CA August 1999 - August 2001 Research Assistant I

May 2000 – August 2001

Conducted bacterial transformation, electroporation, plasmid purification, and tested for phage contamination.

Cycle sequenced clones (DNA purification and amplification) using V-PREP (Velocity 11), Jouan-KR422 and Speed Vac Concentrator.

PCR of bacterial g.stock using 96 or 384 Thermocycler and conducted molecular weight determination by way of Agarose Gel Electrophoresis using BioRAD Power/PAC 300 and Alphalmager 2200 V5.5.

Recovered clones; operated and troubleshoot different robotics as necessary. Graveyard Shift Coordinator, Sequencing Associate II August 1999 – May 2000

Sequenced DNA samples using the MegaBACE 2000.

Supervised a group of 8 to 10 personnel in the absence of the group team leader.

Tracked and analyzed DNA sample chromatograms using FileMakerPro and Umpire database.

Troubleshoot equipment problems and performed appropriate hardware changes. Cell No.: 408-***-**** E-mail: adjyv5@r.postjobfree.com Yen My Huynh-Wong Curriculum Vitae Page 5 of 5

VARIOUS EYE HEALTHCARE WORK EXPERIENCE July 1996 - July 2005 EYEXAM 2000 OF CALIFORNIA, INC., LENSCRAFTERS OPTIQUE, MARINA VILLAGE OPTOMETRY, BERRYESSA OPTOMETRY, COSTCO OPTICAL, TURNER EYE INSTITUTE MEDICAL GROUP, INC., KAISER PERMANENTE MEDICAL GROUP, AND SILICON VALLEY EYE PHYSICIANS, Alameda & Santa Clara County Optometric Technician/Assistant, Optician, and Ophthalmic Technician

Maintained patient records and updated and audited Ophthalmology referrals.

Neutralized spectacles with manual and automatic Lensometer.

Performed Applanation Tonometry and Visual Acuity on patients as needed. Instructed and worked up pre and post operative care for patients undergoing eye surgery.

Operated diagnostic machines such as OCT, ORB-scan, and Pachymeter on patients.

Pre-tested patients for visual acuity, color vision, depth perception, glaucoma, and peripheral vision.

Volunteered at various eye healthcare institutions and participated in yearly vision programs for the less fortunate such as the “Give the Gift of Sight”.

EDUCATION

GOLDEN GATE UNIVERSITY, San Francisco, CA December 2018 Master of Business Administration (M.B.A.), With Honors SAN JOSÉ STATE UNIVERSITY, San José, CA May 2005

Major: Bachelor of Arts in Biological Science

Minor: Business

Founder and President of SJSU Badminton Club

Recipient of California Space Grant Scholarship,

Vice-President of SJSU Pre-Optometry Club

CERTIFICATION

SAN JOSÉ STATE UNIVERSITY / NASA AMES RESEARCH CENTER, San José & Moffett Field, CA 2001/2002 - 2003

Animal Handler Certification, Chemical Hygiene for Laboratories, and Personal Protective Equipment

Chemical Safety Seminar, Biological Laboratory Safety Seminar WORKING WORDS, INC., Foster City, CA 2015

Certified in writing effective investigation reports for Gilead Sciences, Inc. SKILLS

APPLCATIONS/SOFTWARE/SYSTEMS:

Adobe Acrobat, Auditopia, ComplianceWire, Conga, Documentum, FileMakerPro, LIMS, MS Suite (Access, Excel, Project, Word, Visio), Oracle ERP, SAP, SharePoint, Systat, TrackWise, and Veeva Vault (QualityDocs, Deviation, CAPA, Change Control, Complaint, Continuous Improvement, Audit) LANGUAGES:

Fluent in English, Chiu Chow, Cantonese and comprehend Mandarin and Vietnamese.

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