Laura Jones

Vice President, Quality and Regulatory Affairs @Biogennix

Irvine, CA, US
EMAILS
l•••••@biogennix.com
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Oct 2022 — Present

Vice President, Quality and Regulatory Affairs @Biogennix

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Irvine, CA, US

EDUCATION

N/A

American College of Law

J.D., Law

N/A

Louisiana State University

Ph.D., Microbiology

N/A

University of Wisconsin-Madison

MBA, Management/Marketing

N/A

San Diego State University

M.S., Regulatory Affairs

SKILLS

Analytical ChemistryMedical DevicesClinical DevelopmentCapaCRODesign ControlBiologicsQuality AssuranceRegulatory RequirementsIndQuality OperationsComputer System ValidationSterility AssuranceVaccinesRegulatory AffairsLifesciencesSupply ManagementTrainingGlpCleaning ValidationChange ControlCross-Functional Team LeadershipPharmaceutical IndustrySopFda21 Cfr Part 11FormulationClinical TrialsBiotechnologyDrug DevelopmentGcpBiopharmaceuticalsGxpQuality AuditingAseptic ProcessingPharmaceuticsIso 13485MicrobiologyProduct DevelopmentTechnology Transfer

ABOUT LAURA JONES

Proven leader with over 25 years of experience in biotechnology, pharmaceuticals, biologics, contract manufacturing, and medical devices. Expertise in Quality Assurance, Quality Control, auditing (external, internal, supplier management), Quality Systems (document control, change control, complaint handing), compliance, training, validation, sterility assurance, and pre-IND, IND and ANDA submissions. Experience in implementation and managing GxP quality management and compliance systems. Successful management of regulatory inspections.

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