Yang Yang
Manager, Quality Compliance, Pharmacovigilance, Quality Systems
- Role
- Quality Compliance Manager at Cytokinetics
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Yang Yang
Highly motivated Quality professional with 10+ years experience in pharmaceutical and gene-therapy industry. Extensive experience managing Quality Compliance and Quality System, experienced with various state and national health authority inspections, and partner audits. Self-starter with proven ability to take on new challenges and produce results. Experienced in phase appropriate application and improvement of quality principles. Demonstrated knowledge of regulatory requirements and industry standards (e.g. US CFR Title 21 Parts 11, 210, 211; EU GMP Annex 11; ICH Q7, Q9, Q10; GAMP 5)Skills:• Adept in performing deviation investigation, OOS investigations, CAPA implementation, and Change Management.• Management of company-wide QMS to ensure timely closure of quality system documents.• Leading the preparation activities and managing war rooms during customer audits and regulatory inspections.• Management of the company-wide GxP equipment program.• Expertise in managing electronic Learning Management Systems such as ComplianceWire and MasterControl.• Computer Software: MasterControl, ComplianceWire, Veeva RIM, eMaint CMMS
Experience
Quality Compliance Manager
Sep 2024 — Present
Manage the Clinical and Commercial Product Complaint program.• Oversee the GxP Computerized System Supplier Oversight Program.• Lead the implementation of Product Recall process.• Establish Quality Compliance metrics for Management Review and process improvement.• Establish and maintain a company-wide AE/PC training program.• Lead the preparation and hosting of internal audits.• Perform onsite and remote GxP supplier audits.• Lead the implementation of commercial stage processes.• Lead the configuration and deployment of an Electronic Inspection Management system.
Education
University of California, Berkeley
Bachelor of Science (B.S.), Microbial Biology
Skills
- Hplc
- Cell Culture
- Elemental Analysis
- Gmp
- Change Control
- Polarimetry
- Quality System
- Mass Spectrometry
- Total Organic Carbon Analysis
- Microscopy
- Capa
- Toc
- Gas Chromatography
- Analytical Methods Development
- Oos
- Ftir
- Quality Investigations
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