Sharon Ballesteros
Vice President Regulatory and Clinical Development at Volition | San Diego Metropolitan Area
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Sharon Ballesteros serves as the Vice President of Regulatory and Clinical Development at Volition, where she plays a pivotal role in shaping the regulatory landscape and clinical strategies for the company’s groundbreaking Nu.Q® products. With a deep expertise in quality management systems (QMS) and clinical study design, Sharon is dedicated to ensuring that Volition's innovative solutions not only meet but exceed the rigorous standards set by regulatory bodies such as the FDA and ISO. Her leadership is characterized by a commitment to 'right-sized' quality systems that are both efficient and effective, allowing for streamlined clinical development processes.
In her current role, Sharon has successfully provided global regulatory and quality input, establishing a robust electronic Document Management System (eDMS) that enhances compliance and operational efficiency. She has also laid the groundwork for transferring manufacturing capabilities to a U.S.-based Contract Manufacturing Organization (CMO), ensuring that production aligns with both regulatory requirements and the high-quality standards expected in the life sciences sector.
Sharon's strategic oversight extends to the design and execution of clinical studies in collaboration with Contract Research Organizations (CROs), where she has spearheaded initiatives such as breakthrough device requests, positioning Volition at the forefront of innovation in healthcare diagnostics. Her proficiency in data analysis and process simulation further strengthens her ability to lead complex projects, making her an invaluable asset to the Volition team. With a strong foundation in matrix leadership and a passion for advancing healthcare solutions, Sharon Ballesteros is committed to driving the success of Volition’s mission to revolutionize cancer diagnostics.
Vice President Regulatory and Clinical Development at Volition in July 2023 to November 2024
U.S. Head of Quality and Development Process at Volition in April 2022 to July 2023
Sr. Director, Design Control at GRAIL, Inc. in September 2020 to April 2022
Faculty Lecturer, Biostatistics at California State University San Marcos in August 2020 to January 2022
Manager (Quality Assurance), Quality Engineer at Agena Bioscience in June 2019 to August 2020
Sr. Quality Engineer at Agena Bioscience in April 2018 to June 2019
Sr Manager, PPI Business Systems (Lean) at Thermo Fisher Scientific in August 2017 to March 2018
Sr. Manager, Program Management, CSD Next Generation Sequencing at Thermo Fisher Scientific in November 2016 to July 2017
Program Manager at Alere Inc. in January 2015 to October 2016
Senior Manager Project Management (Global PMO) at Siemens Healthcare in July 2013 to October 2015
Senior Program Manager at Siemens Healthcare in October 2011 to July 2013
Program Manager at Siemens Healthcare in January 2005 to January 2011
Biostatistician at Siemens Healthcare in January 1999 to January 2005
Statistical Analyst / Researcher at California Department of Health Services, Office of AIDS in January 1997 to January 1999
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Microsoft Excel
Information Security
Customer Service
Communication
Usability
Statistical Process Control (SPC)
Small and Medium-Sized Enterprises (SME)
Medical Device Regulation (MDR)
IEC
Managed Detection and Response (MDR)
Concept Generation
Executive Visibility
Driving Results
Budgeting
Regulatory Compliance
PMO set-up
Clinical Development
Agile Methodologies
Auditing
Statistical Modeling
Continuous Improvement
Good Clinical Practice (GCP)
Data Management
Management
statistic
SAS (Software)
Statistical Programming
Statistical Data Analysis
Clinical Trial Management System (CTMS)
Team Motivation
Matrix Leadership
Business Case Preparation
Clear Vision
Global Initiatives
Resourcing Strategy
Compliance Assessments
Quality Risk Management
Preventive Actions
Quality Metrics
Presentations
Internal Audits
Corrective Actions
Regulatory Standards
Clinical Quality
Program Management
Strategic Planning
Statistics
Study Design
Regulatory Requirements
SAS programming
Project Management
Clinical Study Design
Software Project Management
Agile Project Management
Cross-functional Team Leadership
Healthcare
Clinical Trials
Medical Devices
Process Improvement
MS Project
SAS
Data Analysis
Quality Assurance
PMP
Analysis
Lifesciences
FDA
Six Sigma
Vendor Management
Biotechnology
Quality Management
Infectious Diseases
Product Development
Validation
Leadership
Employee Training
PMP Training
Visio
R&D
Project Portfolio Management
Software Documentation
Team Leadership
21 CFR Part 11
PMO
Process Simulation
SDLC
Business Process Improvement
Business Process
Resource Management
Integration
Microsoft Project
Life Sciences
Research and Development (R&D)
U.S. Food and Drug Administration (FDA)
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Discover more about VolitionWhat is Sharon Ballesteros email address?
Email Sharon Ballesteros at [email protected]. This email is the most updated Sharon Ballesteros email found in 2026.
How to contact Sharon Ballesteros?
To contact Sharon Ballesteros send an email to [email protected]. (updated on October 31, 2024)
What company does Sharon Ballesteros work for?
Sharon Ballesteros works for Volition
What is Sharon Ballesteros's role at Volition?
Sharon Ballesteros is Vice President Regulatory and Clinical Development
What is Sharon Ballesteros's Phone Number?
Sharon Ballesteros's phone (**) *** *** 332
What industry does Sharon Ballesteros work in?
Sharon Ballesteros works in the Biotechnology Research industry.
Sharon Ballesteros Email Addresses
Sharon Ballesteros Phone Numbers
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