Mony Clark
Operations Quality Management System Strategy Enabling Lead at Roche | San Diego, California, United States
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Mony Clark serves as the Director of Quality Assurance at GenMark Diagnostics, where she plays a pivotal role in ensuring the highest standards of quality and compliance within the clinical diagnostics landscape. With a robust background in clinical, pharmaceutical, and medical device manufacturing, Mony brings a wealth of expertise to her position, particularly in overseeing QA teams responsible for critical functions such as product release, non-conformance (NC) management, deviation (DV) investigations, and Quality Management System (QMS) data analytics. Her leadership extends to managing Corrective and Preventive Actions (CAPAs), document control, change management, and training initiatives, all of which are essential for maintaining compliance with stringent regulatory requirements set forth by the U.S. Food and Drug Administration (FDA).
In her role, Mony is not only focused on operational excellence but also on fostering a culture of continuous improvement within her teams. She establishes clear goals and objectives, prioritizing daily tasks to ensure that her QA teams operate efficiently and effectively. Mony’s commitment to mentorship is evident as she guides a talented group of QA Managers and Senior Managers, empowering them to excel in their roles while cultivating their professional development.
As the Diversity and Inclusion (D&I) Lead at GenMark, Mony is dedicated to advancing the company's strategic initiatives in this critical area. She actively engages with her team and employees to understand their needs, ensuring that GenMark fosters an inclusive environment that values diverse perspectives. Mony’s multifaceted expertise in quality systems, cGMP manufacturing, and supplier quality management positions her as a key player in driving both quality assurance and organizational culture forward in the rapidly evolving diagnostics industry.
Operations Quality Management System Strategy Enabling Lead at Roche in May 2024 to Present
Director QA at GenMark Diagnostics in November 2021 to May 2024
Senior Manager, QA Compliance at GenMark Diagnostics in March 2021 to November 2021
Quality Assurance Compliance Manager at GenMark Diagnostics in January 2020 to March 2021
Quality Compliance, Internal Audit Program Manager at Bayer in August 2016 to January 2020
Consultant, Inspection and Supplier Management at Gilead Sciences in January 2015 to July 2016
Quality Assurance Manager at Invivoscribe in June 2013 to January 2015
Senior QA Specialist at Invivoscribe in January 2013 to June 2013
QA/QC Supervisor at Teleflex Incorporated in February 2012 to December 2012
Senior QA Aseptic Specialist at NextPharma in February 2008 to February 2012
QA Validation Specialist at MicroConstants, Inc. in January 2007 to February 2008
Research Assistant, Biochemistry at Cengent Therapeutics in January 2005 to November 2006
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Quality System
Quality Assurance
Quality Auditing
Internal Audit
External Audit
Validation
Environmental Monitoring
FTIR
HPLC
PCR
ELISA
Western Blotting
Protein Crystallization
Protein Purification
Analytical Chemistry
Analytical Skills
Gel Electrophoresis
Protein Chromatography
Analytical Instruments
Data Analysis
Data Entry
Production Managment
cGMP manufacturing
cGLP
CRO
Project Management
Microsoft Office
SAP
Training
510k
Quality Control
Batch Release
Aseptic Processing
Aseptic Technique
Medical Devices
Pharmaceutical Industry
Pharmacokinetics
Clinical Study Design
Medical Device and Pharmaceutical Labeling
FDA
GMP
Change Control
CAPA
SOP
ISO 13485
GLP
Biotechnology
ISO
U.S. Food and Drug Administration (FDA)
Good Laboratory Practice (GLP)
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Discover more about RocheWhat is Mony Clark email address?
Email Mony Clark at [email protected]. This email is the most updated Mony Clark email found in 2026.
What is Mony Clark phone number?
Mony Clark phone number is +16179810052.
How to contact Mony Clark?
To contact Mony Clark send an email to [email protected]. If you want to call Mony Clark try calling on +16179810052.
What company does Mony Clark work for?
Mony Clark works for Roche
What is Mony Clark's role at Roche?
Mony Clark is Operations Quality Management System Strategy Enabling Lead
What industry does Mony Clark work in?
Mony Clark works in the Medical Equipment Manufacturing industry.
Mony Clark Email Addresses
Mony Clark Phone Numbers
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