Weirong Hu
- Role
- Program Manager, Clinical Quality Assurance at AbbVie
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Weirong Hu
RQAP-GCP certified CQA professional with 10+ yrs of clinical GCP QA experience; extensive…
Experience
Program Manager, Clinical Quality Assurance
Mar 2021 — Present
Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management; • Assess the success and effectiveness of the quality system and assure inspection readiness by designing an audit program of internal and external compliance audits and applicable assessments; • Interpret, explain and apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activities; • Interact with Development Operations organization and supporting functions to ensure quality compliance across all aspects of clinical development; • Identify and mitigate potential clinical quality risks and escalate to management; • Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities; • Provide project/program leadership in quality as a team member across clinical development functions and lead the effort to articulate and present an integrated cross-functional and comprehensive quality strategy plan; • Identify and implement balanced fit-for-purpose quality management; • Serve as the primary program quality liaison during health authority inspections.
Skills
- Auditing
- Clinical Development
- CRO
- Gcp
- Fda
- Capa
- Quality Assurance
- Gmp
- Clinical Monitoring
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