Database Administration Coordinator, ITIL Change Management
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AstraZeneca विज्ञान-आधारित बायोफार्मास्युटिकल कंपनी है, जो प्रमुख स्वास्थ्य चुनौतियों के लिए प्रिस्क्रिप्शन दवाओं का विकास और व्यावसायीकरण करती है। इसका कार्य ऑन्कोलॉजी, हृदय एवं रक्तवाहिका संबंधी, गुर्दे और चयापचय संबंधी स्थितियों तथा श्वसन रोगों पर केंद्रित है। कंपनी औषधीय अनुसंधान को विकास और वैश्विक स्तर पर दवाओं की उपलब्धता के साथ जोड़ती है। 100 से अधिक देशों में संचालन के साथ, AstraZeneca ऐसे दलों को एकजुट करती है जो उपचारों को आगे बढ़ाने और दुनिया भर के रोगियों के स्वास्थ्य परिणामों में सुधार लाने पर केंद्रित हैं।
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.
विवरण
- 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.
आवश्यकताएँ
- 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.
लाभ
- Full-time role.
- Equal opportunity for people of all backgrounds.
- A welcoming, inclusive team with diverse perspectives.
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