Dongmei H.
Quality & Clinical Quality and Compliance Leader| Strategic Thinker | Team Collaborator | Continuous Learner
- Role
- Director Clinical Process Compliance at AbbVie
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Dongmei H.
Clinical Compliance Leader with a proven record of leading the design, implementation, and optimization of global Clinical Quality Management Systems and Quality Management Systems across pharmaceutical, biopharmaceutical, biotechnology, and medical device industries. Strategic and collaborative leader recognized for driving GCP compliance, inspection readiness, and a culture of quality and continuous improvement. Trusted advisor skilled in clinical quality governance, CAPA effectiveness, process optimization, audit strategy, change management, and training excellence to ensure operational integrity and regulatory success.I lead a team focused on ensuring that regulatory compliance, Good Clinical Practice, subject safety, and data integrity are maintained across clinical trials while also encouraging innovative research solutions.Additional QualificationsProfessional certifications: Certified Quality Auditor, ASQ (American Society for Quality), 2013; Certified Medical Device Auditor (CMDA), ASQ (American Society for Quality), 2015; CQI/IRCA Certified Quality Management Systems Lead Auditor (incorporating ISO 13485:2016 and MDSAP requirements), 2017.During my free time, I love to do volunteering, gardening and cook different countries\' cuisines.
Experience
Director Clinical Process Compliance
Jan 2026 — Present
Education
Lehigh University
M.S., Analytical Chemistry
2004 — 2006
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