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„AstraZeneca“ yra mokslu pagrįsta biofarmacijos bendrovė, kurianti ir komercializuojanti receptinius vaistus svarbiausioms sveikatos problemoms spręsti. Jos veikla apima onkologiją, širdies ir kraujagyslių, inkstų bei medžiagų apykaitos ligas ir kvėpavimo takų ligas, derinant farmacijos tyrimus, vaistų kūrimą ir pasaulinį tiekimą. Daugiau nei 100 šalių veikianti „AstraZeneca“ suburia komandas, siekiančias tobulinti gydymo būdus ir gerinti pacientų gydymo rezultatus visame pasaulyje.
Senior Clinical Quality Manager, China
Lead clinical quality work in China for AstraZeneca, covering audits, training, and GCP compliance. Advise DevOps teams on local procedures and regulations while driving improvements in clinical quality.
Aprašymas
- Oversee assigned local quality management programs from design through implementation.
- Carry out accompanied site visits and internal quality reviews.
- Equip local management with DevOps quality measures and dashboards.
- Guide DevOps colleagues on AstraZeneca procedures, local clinical documents, quality and compliance guidance, ICH-GCP, industry standards, and applicable regulations.
- Improve the CQM helpdesk on an ongoing basis.
- Manage Local Procedural Documents through drafting, publication, training, rollout, upkeep, and archiving.
- Work with QA as the DevOps liaison to shape audit plans and coordinate audits with study teams.
- Support DevOps teams in addressing audit and inspection observations.
- Analyze trends in audit and inspection findings and share lessons learned.
- Oversee local training platforms and programs from planning to delivery.
- Direct DevOps clinical compliance work, including privacy and cross-border data transfer reviews.
- Take part in process reviews to support compliance with regulations in China.
Reikalavimai
- Bachelor’s degree in a healthcare-related discipline or equivalent qualification.
- At least 8 years of experience in Clinical Operations or a related area, including 4 years in clinical quality management.
- Substantial experience with China GCP inspections and a thorough understanding of GCP.
- Working knowledge of study management, site management and monitoring, and local regulations.
- Fluent English, spoken and written.
- Strong clinical process design and improvement skills.
- Strong training capabilities.
- Leadership skills to advance cross-functional projects and initiatives.
- Learns quickly, adapts readily, and brings accountability and a strong focus on results.
- Strategic outlook and ability to anticipate future needs.
- Skills in risk and crisis management.
- Ability to lead change constructively.
Privalumai
- Full-time role.
- Equal opportunity for people of all backgrounds.
- A welcoming, inclusive team with diverse perspectives.
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