Heather Dowd
Senior Director, Quality Management at Flourish Research
- Role
- Senior Director, Quality Management at Flourish Research
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Heather Dowd
Quality-driven clinical research professional with a passion for supporting and guiding others to meet their compliance and regulatory goals through comprehensive quality risk management and process improvement. Experienced in QMS creation, audits/inspections, risk management, regulatory oversight, issue management (RCA, CAPA), and change management/process implementation.
Experience
Senior Director, Quality Management
Apr 2022 — Present
Design, build, implement, and manage companywide Quality Management System• Develop and oversee execution of clinical quality risk management framework• Create and lead Project Quality team in quality compliance oversight and risk management processes across 20+ sites nationwide• Support sites with inspection readiness and preparation, and serve as on-site inspection lead• Oversee internal audit program (sites, systems, processes, vendors), including training staff in audit conduct• Serve as quality lead for new site integrations including risk management oversight• Represent Quality in leadership Quality Forums• Serve as Quality SME within Business Process Management team
Education
Wake Technical Community College
Associate’s Degree, Biopharmaceutical Technology
2010 — 2011
Pima Community College
Associate’s Degree, Legal Assistant Studies
1997 — 1999
The George Washington University School of Medicine and Health Sciences
Master of Science in Health Sciences, Regulatory Affairs
2017 — 2022
International Culinary Center
Grande Diplome - Pastry Studies
2000 — 2001
The George Washington University School of Medicine and Health Sciences
BS Clinical Research Administration, Clinical Research
2013 — 2017
Skills
- Laboratory Skills
- Management
- Analytical Chemistry
- Regulatory Affairs
- Customer Service
- Research
- Quality Control
- Gmp
- Chromatography
- Standard Operating Procedure (Sop)
- Analytical Skills
- Biochemistry
- Electronic Data Capture (Edc)
- Microsoft Powerpoint
- Glp
- Leadership
- Gas Chromatography
- Project Management
- Pharmaceutical Industry
- Gl
- Lims
- Time Management
- Quality Assurance
- Life Sciences
- Hplc
- Microsoft Word
- Operations Management
- Laboratory
- Gcp
- Biotechnology
- Clinical Trials
- Microsoft Excel
- Microsoft Office
- U.s. Title 21 Cfr Part 11 Regulation
- Clinical Research
- Ich
- Ctms
- Clinical Monitoring
- Clinical Trial Management System (Ctms)
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