Our Team
Dalal O. Murgai
Dalal Murgai, Chief Executive Officer and Co-Founder of GXP Quality Systems, has key responsibilities for the overall management of the company, as well as operations in the areas of Preclinical Research and Development, Clinical and the Regulatory submissions development, publishing and filing. Dalal has over 30 years in the biopharmaceutical/ medical research industry, having held positions in Regulatory Affairs and Quality Assurance, preparing technical documents for submission to regulatory authorities and performing quality oversight of preclinical, clinical, and investigational drug manufacturing, testing and control operations. Areas of expertise include GXP compliance, advising on operational issues, managing interactions with regulatory agencies, and preparation and evaluation of SOPs, technical documents and U.S. and global regulatory submissions.
Henry Schea
Henry Schea is Vice President, Manufacturing Services at GXPQS. He has over 40 years in the Pharmaceutical Industry specializing in production of biopharmaceuticals, gene therapies, vaccines and animal health products. His experience spans production of materials from pre-clinical development through commercial manufacturing and includes manual aseptic production of clinical materials through largescale production in RABS and filling lines. Henry recently served for five years as site Quality Head with oversite of manufacturing for multiple products in both clinical and commercial production.
Ashley Hehr
Ashley Hehr, Executive Director of Clinical QA and Operations of GXP Quality Systems, has key responsibility for Clinical Quality Assurance and clinical operations for the company. Ashley has over 15 years of experience in the biopharmaceutical / medical research industry. Ashley initially started her career working as a study research coordinator at an investigator site, then moved into Drug Safety / Pharmacovigilance at a Clinical Research Organization, and then Quality Assurance at a small pharmaceutical company. Areas of expertise include development of internal quality systems including document control, vendor quality programs, employee training, and quality event programs; Internal, vendor, and clinical quality audits; GCP compliance; and Drug Safety and Pharmacovigilance activities including Serious Adverse Event (SAE) case triage and processing, set up and data entry into safety database, narrative writing, coding, and regulatory report preparation.
Mandy Dyer
Mandy Dyer is the Executive Administrator at GXP Quality Systems, LLC. She manages all internal office and administrative activities, on-boards new hires and serves as a liaison with vendors. She also serves as the initial point of contact between executives, potential clients and oversees administrative services and programs to ensure the advancement of the company’s objectives. Mandy has more than twenty years of administrative experience and is responsible for maintaining order and office structure. Her expertise in managing multiple activities, as well as her organizational skills and attention to detail significantly impact and ensure the success of daily operations.
Bruce Little
Bruce Little is our Quality Systems Expert with more than 40 years of experience in all roles of Quality Assurance and Quality Control, and recent experience in remediation activities for 3 different companies in Consent Decree. Mr. Little is currently responsible for the design and implementation of QXPQS’s internal proprietary Quality System, and in the oversight of the internal IT system implementation. Bruce has particular expertise in the development and implementation of Quality Systems, data integrity/governance implementation, electronic document management/change control systems, computerized system validation, laboratory management, and CAPA/complaint management.
Brenda Mcduffie
Brenda McDuffie, Executive Accountant, is responsible for corporate finance and accounting responsibilities and is responsible for all general accounting practices, payroll, budgeting, and development of internal accounting controls, as well as preparing periodic financial statements and reports. She is responsible for developing a comprehensive set of controls designed to mitigate risk, enhance the accuracy of the company’s financial results, and ensure that results comply with generally accepting accounting principles. Brenda has more than 17 years of experience in public accounting with numerous audits and regulatory compliance engagements. Her expertise includes financial reporting, monitoring debt levels, creating budgets and forecasting the company’s financial success.