Adrienne Hwa Oreilly Ms Cqa Email & Phone Number | Over a decade of industry experience in biotech, pharmaceutical, and combination product development. As a late-stage, small, virtual company's first Quality employee, established Phase III/pre-commercialization quality system; product approved by FDA fall 2019 and EMA spring 2021. As another late-stage company's first Quality employee, developed the company's novel quality system, addressed key compliance gaps, and successfully hosted regulatory agency inspection 16 months after hire. Subject matter expertise in creation and management of robust phase-appropriate (from Phase I-III/pre-commercialization) quality systems: vendor and material qualification, batch record review and release (including QP release), material movement and inventory management, internal and external audits, management review, document control, training, deviation, CAPA, and complaint programs, SOP writing and improvement, risk management, out of specification procedures, device design control, purchasing controls, creation of quality manuals, site master files, and quality agreements, GCP and GVP QA, and for two companies, implemented (including configuring and validating) and served as sysadmin of MasterControl as an electronic quality management system (eQMS). Served as sysadmin for PSC Biotech's ACE eQMS, and business owner/ process owner for the implementation of Veeva's QualityDocs and Training modules. Experience leading and participating in domestic and international GMP (20+) and GCP audits, hosting regulatory agency inspections, client audits, management review meetings, and internal audits. Earlier industry experience includes managing, under the CEO, a small virtual company preparing for late-stage manufacturing, QA consulting - establishing quality systems at small, late-stage virtual companies (including packaging and labeling facilities, warehouses, and in-vitro diagnostics companies), clinical trial design, writing clinical trial protocols, and conducting monitoring, CMO vetting, selection, and tech transfer, qualification and oversight of GLP vendors, patent defense, writing FDA IND updates, writing publications, and presenting posters and oral presentations at domestic and international conferences.

Adrienne Hwa Oreilly Ms Cqa

Over a decade of industry experience in biotech, pharmaceutical, and combination product development...
Las Vegas, Nevada, United States

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Adrienne Hwa Oreilly Ms Cqa’s Email areilly@respivant.com

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Adrienne Hwa Oreilly Ms Cqa’s Location Las Vegas, Nevada, United States

Adrienne Hwa Oreilly Ms Cqa’s Current Industry Qbdvision

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Work Experience

Qbdvision

Senior Director, QA and Validation

2022-06-01 00:00:00 - Present

Immunovant

Quality Director, Combination Products

2020-09-01 00:00:00 - 2022-05-01 00:00:00

Respivant Sciences

Associate Director, Quality Assurance

2020-02-01 00:00:00 - 2020-09-01 00:00:00

Savara

Quality Assurance Consultant

2019-10-01 00:00:00 - 2020-01-01 00:00:00

Xeris Pharmaceuticals

Quality Assurance Manager

2015-03-01 00:00:00 - 2017-07-01 00:00:00

City Of Irving Board Of Health

Board Member

2012-05-01 00:00:00 - 2015-03-01 00:00:00

Arog Pharmaceuticals

Senior Research Analyst/ Team Leader

2013-05-01 00:00:00 - 2015-03-01 00:00:00

Mentrik Biotech

Senior Research Analyst serving as Project Manager

2012-07-01 00:00:00 - 2015-03-01 00:00:00

Oncology Network For Excellence

Research Analyst

2011-09-01 00:00:00 - 2011-12-01 00:00:00

Oklahoma State University

Graduate Teaching Assistant

2011-01-01 00:00:00 - 2011-05-01 00:00:00

Columbia University Irving Medical Center

Research Intern

2008-05-01 00:00:00 - 2008-08-01 00:00:00

University Of North Texas

Research Intern

2006-10-01 00:00:00 - 2007-12-01 00:00:00

Moscow State University

Internal Medicine Intern

2007-05-01 00:00:00 - 2007-06-01 00:00:00

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FAQ About Adrienne Hwa Oreilly Ms Cqa

Adrienne Hwa Oreilly Ms Cqa is located at
Las Vegas, Nevada, United States

Adrienne Hwa Oreilly Ms Cqa is a Over a decade of industry experience in biotech, pharmaceutical, and combination product development. As a late-stage, small, virtual company's first Quality employee, established Phase III/pre-commercialization quality system; product approved by FDA fall 2019 and EMA spring 2021. As another late-stage company's first Quality employee, developed the company's novel quality system, addressed key compliance gaps, and successfully hosted regulatory agency inspection 16 months after hire. Subject matter expertise in creation and management of robust phase-appropriate (from Phase I-III/pre-commercialization) quality systems: vendor and material qualification, batch record review and release (including QP release), material movement and inventory management, internal and external audits, management review, document control, training, deviation, CAPA, and complaint programs, SOP writing and improvement, risk management, out of specification procedures, device design control, purchasing controls, creation of quality manuals, site master files, and quality agreements, GCP and GVP QA, and for two companies, implemented (including configuring and validating) and served as sysadmin of MasterControl as an electronic quality management system (eQMS). Served as sysadmin for PSC Biotech's ACE eQMS, and business owner/ process owner for the implementation of Veeva's QualityDocs and Training modules. Experience leading and participating in domestic and international GMP (20+) and GCP audits, hosting regulatory agency inspections, client audits, management review meetings, and internal audits. Earlier industry experience includes managing, under the CEO, a small virtual company preparing for late-stage manufacturing, QA consulting - establishing quality systems at small, late-stage virtual companies (including packaging and labeling facilities, warehouses, and in-vitro diagnostics companies), clinical trial design, writing clinical trial protocols, and conducting monitoring, CMO vetting, selection, and tech transfer, qualification and oversight of GLP vendors, patent defense, writing FDA IND updates, writing publications, and presenting posters and oral presentations at domestic and international conferences.

Adrienne Hwa Oreilly Ms Cqa currently works in the Qbdvision |

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Adrienne Hwa Oreilly Ms Cqa has prior
experience in the following industries:
Immunovant | Respivant Sciences | Savara | Xeris Pharmaceuticals | City Of Irving Board Of Health | Arog Pharmaceuticals | Mentrik Biotech | Oncology Network For Excellence | Oklahoma State University | Columbia University Irving Medical Center | University Of North Texas | Moscow State University

Adrienne Hwa Oreilly Ms Cqa has the following professional experience:
Qbdvision | Immunovant | Respivant Sciences | Savara | Xeris Pharmaceuticals | City Of Irving Board Of Health | Arog Pharmaceuticals | Mentrik Biotech | Oncology Network For Excellence | Oklahoma State University | Columbia University Irving Medical Center | University Of North Texas | Moscow State University