Phynese L
Senior Manager, GxP Compliance Audit at BioMarin Pharmaceutical Inc. | Charlotte Metro
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As Senior Manager of GxP Compliance Audit at BioMarin Pharmaceutical Inc., Phynese L. plays a pivotal role in ensuring the integrity and compliance of the company’s quality systems across both domestic and international operations. Leveraging her extensive expertise in GxP regulations, she leads comprehensive external and internal audits, meticulously assessing adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other regulatory standards. Her role involves serving as a subject matter expert, providing well-researched, fact-based insights on complex compliance issues that often lack clear precedence, thereby guiding strategic decision-making and risk mitigation efforts.
Phynese’s current projects include overseeing audits of clinical trial sites, manufacturing facilities, and quality management systems to ensure alignment with FDA regulations and international standards. She actively collaborates with cross-functional teams—including clinical, regulatory, and quality assurance—to identify areas for process improvement and implement robust corrective and preventive actions (CAPAs). Her expertise in quality control, software quality assurance, and change management enables her to streamline audit processes, enhance audit readiness, and foster a culture of continuous improvement within the organization.
Her deep understanding of quality management principles and lean management techniques supports BioMarin’s commitment to delivering high-quality, compliant products to patients worldwide. Through her strategic communication and relationship-building efforts with commercial and clinical partners, Phynese ensures transparency and alignment across departments, reinforcing BioMarin’s reputation for excellence in GxP compliance and regulatory readiness.
Senior Manager, GxP Compliance Audit at BioMarin Pharmaceutical Inc. in April 2023 to Present
Associate Principal Consultant at SciLucent, Inc. in March 2022 to March 2023
Lead Auditor at Be The Match BioTherapies in March 2018 to February 2022
Senior Auditor and CAPA Analyst at AmerisourceBergen in November 2015 to March 2018
Quality Assurance Supervisor at Octapharma Plasma, Inc. in March 2014 to October 2015
Principal Associate/ Quality at American Red Cross Biomedical Services in July 2007 to October 2013
Quality Assurance Auditor/Consultant at CRI Worldwide in May 2006 to July 2007
Laboratory Quality Specialist at American Red Cross, Philadelphia National Testing Lab in January 1999 to July 2007
Laboratory Technician at Coriell Institute for Medical Research in November 1996 to January 1999
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Chowan University, BS, October 1991 to October 1995
Chowan University, AS, October 1991 to October 1994
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21 CFR
Complaint Management
Quality Control
Auditing
Internal Audits
Good Clinical Practice (GCP)
Clinical Trials
External Audit
Quality Management
FDA GMP
GMP
CAPA
FDA
Root Cause Analysis
Quality Auditing
Six Sigma
Data Analysis
Project Management
Change Management
FMEA
Risk Assessment
Software Quality Assurance
SPC
GCPs
Records Management
Lean Management
Lean Six Sigma
Minitab
Employee Training
Process Improvement
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Discover more about BioMarin Pharmaceutical Inc.What is Phynese L email address?
Email Phynese L at [email protected]. This email is the most updated Phynese L's email found in 2026.
How to contact Phynese L?
To contact Phynese L send an email to [email protected]. (updated on February 16, 2025)
What company does Phynese L work for?
Phynese L works for BioMarin Pharmaceutical Inc.
What is Phynese L's role at BioMarin Pharmaceutical Inc.?
Phynese L is Senior Manager, GxP Compliance Audit
What is Phynese L's Phone Number?
Phynese L's phone (**) *** *** 248
What industry does Phynese L work in?
Phynese L works in the Pharmaceuticals industry.
Phynese L Email Addresses
Phynese L Phone Numbers
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