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AstraZeneca
AstraZeneca
Sponsor pentru viza H1BAsistență medicalăBiotehnologieProduse farmaceutice
AstraZeneca este o companie biofarmaceutică orientată spre știință, care dezvoltă și comercializează medicamente eliberate pe bază de prescripție pentru provocări majore din domeniul sănătății. Activitatea sa acoperă oncologia, afecțiunile cardiovasculare, renale și metabolice, precum și bolile respiratorii, îmbinând cercetarea farmaceutică cu dezvoltarea și furnizarea globală a tratamentelor. Cu operațiuni în peste 100 de țări, AstraZeneca reunește echipe concentrate pe avansarea tratamentelor și îmbunătățirea rezultatelor pentru pacienții din întreaga lume.
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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.

CNChinaLa sediuNormă întreagăSeniorLimbă Obligatorie: englezăOperațiuni clinice
Google Cloud Platform

Descriere

  • 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.

Cerințe

  • 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.

Beneficii

  • Full-time role.
  • Equal opportunity for people of all backgrounds.
  • A welcoming, inclusive team with diverse perspectives.

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