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Felicia utilizes over 25 years of R&D, Regulatory Affairs and Quality Assurance expertise to advise clients on the development, implementation and management of quality systems to ensure Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice and Pharmacovigilance compliance. Felicia provides consulting services on a variety of quality compliance topics including: GxP Compliance/Inspection Readiness/Training, Regulatory Risk/Data Integrity/Failure Investigation/ Change Control Evaluation, and Corrective Action and Preventive Action/Product Complaint Assessments.
She consults with client senior management to develop effective strategies and responses to regulatory authority findings (e.g., FDA 483, Warning Letters, EMA and Health Canada Inspection Observations) and performs verification activities for enforcement sanctions (i.e., Warning Letters, Consent Decrees) and activities under attorneyclient privilege. In addition, she performs systemsbased audits of sterile and non-sterile, API, pharmaceutical, radiopharmaceutical, and biological manufacturing operations. Prior to joining Parexel, Felicia held senior positions in Quality Assurance for Astellas, Acambis, (now Sanonfi Pasteur), AtheroGenics Inc., Glaxo SmithKline/SmithKline Beecham and served as Adjunct Professor (PartTime) for Northeastern University.
Felicia is currently a Master of Science degree candidate in Bioscience Regulatory Affairs at Johns Hopkins University. She earned a Master in Management in Business Administration and a Project Management Certificate from Penn State University, a B.S. in Biology from Virginia Tech. She completed Management Development and Leadership Executive Education courses at Emory University, and holds a professional certification in Regulatory Affairs.
Felicia has served on committees of multiple pharmaceutical industry organizations and presented on compliance topics at professional association meetings.
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