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QA Associate DirectorAstraZeneca · Qingdao Site
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AstraZeneca

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QA Associate Director

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🗓️ Posted 2026-09-29 Qingdao Site Full-time Hybrid ICT
💰 Salary Not shared 📊 Market 60,000 GBP–100,000 GBP/mo

About the Company

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio Pharmaceutical Manufacturing Specialties: Pharmaceutical, Biopharmaceutical, Innovation, Research and development, Global business

About the Role

This is a role as the principal quality assurance engineer in the leading edge project of new pMDI manufacturing facility in China.

Responsibilities

  • ● Provide Quality support to achieve the pMDI project milestones.
  • ● Ensure compliance with GMP requirements during the design, construction, start-up, validation of Qingdao capital project initiative.
  • ● Ensure GMP compliance and operational effectiveness of the validation program.
  • ● Cross functionally interact with both internal and external colleagues in Operations and Quality to ensure full compliance with AZ standards and local regulations.
  • ● Design and lead the automation digital processes to support QA business.
  • ● Mentor, train, and develop QA and other engineering or operations staff and interns in relevant technical subjects and contribute to GMP training activities.
  • ● Supervise and oversee contractors and intern activities as required
  • ● Provide Quality expertise to the project and later site.
  • ● Influence site management and propose solution options to improve and or resolve technical challenges.
  • ● Support development of GPQS, ECMS, GVLMS database and provide oversight and expertise.
  • ● Provide oversight or ownership of QMS including validation, change controls, deviations, and related infrastructure activities within the Qingdao Operations site.
  • ● Interface with engineering IT, QC, manufacturing and technical functions on capital projects and proactively ensure GMP compliance during the design, construction and start up phases of the project.
  • ● Develop and drive necessary departmental process, documentation and training.
  • ● Develop and maintain technical competency and collaborate with counterparts in engineering, IT, QC, manufacturing and technical functions to provide Quality oversight in designated projects and activities.
  • ● Support quality assurance efforts for GMP related facility and equipment systems to ensure full GMP compliance.
  • ● Conduct activities and interactions consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role.
  • ● Ensure and monitor compliance by team members and third parties by positively reinforcing the Code of Ethics and all relevant AstraZeneca Policies and Standards, ensuring completion of all required training, fostering a culture of openness in which employees are comfortable raising questions or concerns, and immediately addressing and reporting instances of non-compliance.

Requirements

  • ● Expert level understanding of China legislation, cGMPs, Validation and Quality Systems, specifically deviations and change controls
  • ● Maintain current knowledge of regulatory and industry trends
  • ● Capable of influencing stakeholders and partners and be able to effectively make decisions for quality assurance issues