Manager, HGR Excellence
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Shanghai • 🇨🇳 China
Visit company websiteJob Level
SeniorLead
About the role
- Responsible for HGR process excellence and HGR risks oversight, including but not limited to process optimization and training, due diligence, global Initiatives, governance management, audit and Inspection readiness.
- Responsible for China HGR overall compliance oversight to ensure all required HGR related activities are properly delivered.
- Lead communication and alignment with R&D China, Science Units and other counterpart relevant China/global functions on related HGR topics.
- Responsible for building up strong engagement and collaboration with external authority and industry.
- As process owner, lead the development and update of SOP, working process, supporting tools and reference.
- Lead development of HGR information management system and ensure it could support oversight and inspection readiness.
- Optimize internal training and knowledge sharing system.
Requirements
- Bachelor degree in healthcare-related field, or equivalent.
- At least 8 years experience in Clinical Operations, including 6 years experience in HGR Management.
- Significant knowledge and experience in HGR inspections and deep understanding of China HGR regulation.
- Ability to continue optimizing HGR relevant process and tools for cross functions, especially for R&D.
- Ability to look for and champion more efficient and effective methods/processes of delivering clinical trials with high HGR compliance.
- Good communication and cross functional collaboration skills.
- Risk and crisis management skills, and good change management skills
- Fluent spoken and written English.
Benefits
- Equal opportunity employer
- Professional development opportunities
- Commitment to building an inclusive and diverse team
- Lifelong learning and growth opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
HGR process optimizationHGR compliance oversightSOP developmentHGR information management systemclinical trialsHGR inspectionsChina HGR regulationrisk managementchange management
Soft skills
communicationcross functional collaborationengagementleadershiptrainingknowledge sharing
Certifications
Bachelor degree in healthcare-related field