Associate Director, Cmc Project Management
Current
Aug 2024 - Present
AeroLeads people directory · profile
Sheila Chou Email & Phone Number
Quality, Drug Safety, Project Management
at
Exelixis
LinkedIn matched
✓ Verified May 2026
3 data sources
Profile completeness 86%
Current company
Role
Quality, Drug Safety, Project Management
Location
San Francisco Bay Area, United States, United States
Company size
Who is Sheila Chou? Overview
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Quick answer
Sheila Chou is listed as Quality, Drug Safety, Project Management at Exelixis, a company with 51 employees, based in San Francisco Bay Area, United States, United States. AeroLeads shows a matched LinkedIn profile for Sheila Chou.
Sheila Chou previously worked as Associate Director, CMC Project Management at Exelixis and Associate Technical Director, Quality at Exelixis. Sheila Chou holds Bachelor Of Science, Biological Sciences; Molecular And Cellular Biology from University Of California, Davis.
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Exelixis
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Profile bio
About Sheila Chou
I am an LSS Green Belt (Roche certified, Exelixis certified) with a passion for Compliance, Quality, and Process Excellence. In my 20+ years in the industry, I have gained a broad range of experience across manufacturing, QC, QA, and Pharmacovigilance. I am a Quality professional with a demonstrated history of success in the biotechnology industry including skills such as cGMP practices, Technical Writing, Quality Control laboratory tests, Stability program start-up and maintenance, contract negotiation and account management, Root Cause Analysis and CAPA. My LSS background is the basis for engraining process excellence in all tasks, with a focus on data analysis and root cause-based CAPAs.
Current workplace
Sheila Chou's current company
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Exelixis
9 roles
Sheila Chou work experience
A career timeline built from the work history available for this profile.
Associate Technical Director, Quality
Feb 2022 - Aug 2024
Senior Technical Manager
Provide Quality oversight to internal and external customers.Solve a wide range of difficult Quality issues impacting multiple functions following cGMP standards.Monitor QA activities to evaluate trends, report anomalies, observations and present findings to Quality Review Board and senior management.Support creation, maintenance and review of Risk.
Dec 2020 - Feb 2022
Vendor Lead, Project Manager, Us Drug Safety
Liase with commercial, contract, and clinical teams to ensure strong QMS design of Patient Support Programs provide robust collection of quality safety data and medically relevant information.Assess risks, analyze data trends, and understand business priorities in order to influence Vendor strategies.Act as Pharmacovigilance Subject Matter Expert for.
Jun 2019 - Dec 2020
Qa Specialist Iii
Provide Quality oversight to multiple support groups, including QC laboratories, Raw Materials, Environmental Monitoring and Lot Release.Lead and participate in design and implementation of department and cross-functional initiatives for continuous improvement/team governance.Serve as Quality Oversight and consult for customer groups, across.
Mar 2013 - Jun 2019
Associate Ii
Timely scientific analyses of stability, bulk and release to market samplesPrimary discrepancy assessment for 20 analysts; excellent technical writing and problem solving skillsProficient at multiple systems including Trackwise, LIMS, SAP, MS Project, Visio and MS Office SuiteProject management across multiple sites; remote and global collaborationSkilled.
Jan 2009 - Mar 2013
Senior Quality Analyst
Performance of in-process assays supporting the manufacture of multiple release to market products At ease in a fast paced, dynamic environmentFamiliarity with specifications, COA, trend assessmentAuthored critical reagent qualification reports for internal and external groupsPioneered inventory tracking system which was later implemented across multiple.
Jan 2005 - Dec 2008
Qc Laboratory Operations, Analyst Ii
Chiron, Corp
Conducted in-process, stability, clinical and final container testing for various productsFamiliarity with coulometer, osmometer, wet chemistry techniquesAuthored re-evaluation and cross validation reports to maintain testing resourcesScheduled lab testing activities and lab maintenanceRevised test procedures to reflect best practicesCollaborated with.
Feb 2003 - Dec 2004
Manufacturing Fermentation, Associate Ii
Chiron, Corp
Responsible for the primary fermentation and recovery of marketed productsOperation of 1500L fermentor, clarification centrifuges, and various process vesselsSkilled in aseptic technique, use of LAF and biosafety hoodsActively participated in Manufacturing Safety Committee: Observation Team committed to preventing safety hazards in the workplacePromoted to.
Jan 2001 - Jan 2003
Team & coworkers
Colleagues at Exelixis
Other employees you can reach at exelixis.com. View company contacts for 51 employees →
CL
Carol Lo
Colleague at Exelixis
San Francisco Bay Area, United States
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VL
Vigneshwaran Loganathan
Colleague at Exelixis
Phoenix, Arizona, United States, United States
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SW
Sandra Wiejowski
Colleague at Exelixis
North Chicago, Illinois, United States, United States
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AV
Aditya V.
Colleague at Exelixis
Cupertino, California, United States, United States
View →
MC
Matt Chung
Colleague at Exelixis
San Francisco Bay Area, United States, United States
View →
HL
Hazel Lai, Mph
Colleague at Exelixis
San Francisco Bay Area, United States, United States
View →
CW
Cheryl Watton, Mbbch, Mba
Colleague at Exelixis
Oceanside, California, United States, United States
View →
RN
Roger Neal
Colleague at Exelixis
Indianapolis, Indiana, United States, United States
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NM
Naveen Muppalla
Colleague at Exelixis
San Francisco Bay Area, United States
View →
SR
Shyam R. Iyer
Colleague at Exelixis
United States, United States
View →
Carol Lo
Colleague at Exelixis
San Francisco Bay Area, United States
View →
VL
Vigneshwaran Loganathan
Colleague at Exelixis
Phoenix, Arizona, United States, United States
View →
SW
Sandra Wiejowski
Colleague at Exelixis
North Chicago, Illinois, United States, United States
View →
AV
Aditya V.
Colleague at Exelixis
Cupertino, California, United States, United States
View →
MC
Matt Chung
Colleague at Exelixis
San Francisco Bay Area, United States, United States
View →
HL
Hazel Lai, Mph
Colleague at Exelixis
San Francisco Bay Area, United States, United States
View →
CW
Cheryl Watton, Mbbch, Mba
Colleague at Exelixis
Oceanside, California, United States, United States
View →
RN
Roger Neal
Colleague at Exelixis
Indianapolis, Indiana, United States, United States
View →
NM
Naveen Muppalla
Colleague at Exelixis
San Francisco Bay Area, United States
View →
SR
Shyam R. Iyer
Colleague at Exelixis
United States, United States
View →
2 education records
Sheila Chou education
Bachelor Of Science, Biological Sciences; Molecular And Cellular Biology
University Of California, Davis
Education record
Northgate High School
FAQ
Frequently asked questions about Sheila Chou
Quick answers generated from the profile data available on this page.
What company does Sheila Chou work for?
Sheila Chou works for Exelixis.
What is Sheila Chou's role at Exelixis?
Sheila Chou is listed as Quality, Drug Safety, Project Management at Exelixis.
Where is Sheila Chou based?
Sheila Chou is based in San Francisco Bay Area, United States, United States while working with Exelixis.
What companies has Sheila Chou worked for?
Sheila Chou has worked for Exelixis, Genentech, and Chiron, Corp.
Who are Sheila Chou's colleagues at Exelixis?
Sheila Chou's colleagues at Exelixis include Carol Lo, Vigneshwaran Loganathan, Sandra Wiejowski, Aditya V., and Matt Chung.
How can I contact Sheila Chou?
You can use AeroLeads to view verified contact signals for Sheila Chou at Exelixis, including work email, phone, and LinkedIn data when available.
What schools did Sheila Chou attend?
Sheila Chou holds Bachelor Of Science, Biological Sciences; Molecular And Cellular Biology from University Of California, Davis.
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