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AstraZeneca
AstraZeneca
H1B vīzas sponsorsBiotehnoloģijaFarmaceitiskie produktiVeselības aprūpe
AstraZeneca ir zinātnē balstīts biofarmācijas uzņēmums, kas izstrādā un komercializē recepšu zāles nozīmīgu veselības problēmu risināšanai. Tā darbība aptver onkoloģiju, sirds un asinsvadu, nieru un vielmaiņas slimības, kā arī elpceļu slimības, apvienojot farmācijas pētniecību, zāļu izstrādi un globālu pieejamību. AstraZeneca darbojas vairāk nekā 100 valstīs un apvieno komandas, kas koncentrējas uz ārstēšanas iespēju attīstīšanu un pacientu ārstēšanas rezultātu uzlabošanu visā pasaulē.
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Vakances uzņēmumā

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.

CNĶīnaKlātienēPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuKlīniskās operācijas
Google Cloud Platform

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

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

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