Associate Director Quality Digital
Job Description
- Leading the digital strategy applied in GMP area
- 领导数字化战略在 GMP 领域的应用
- Leading/Implement site quality digital transformation plan, uplifting quality organization digital capability and deliver a competitive advantage to quality business
- 领导/实施工厂质量团队的数字化转型计划，提升质量团队的数字化能力，并为业务创造竞争性优势
- Introduce/implement/support digital solution to achieve the quality improvement area identified.
- 引入/实施/支持数字解决方案以实现在质量领域的改进
- Support digital use cases as Quality SME combined quality professional and digital capability to ensure compliance to PQS, cGMP and regulation interfacing between Quality/compliance and digital operation.
- 作为质量团队专家，支持各类数字化解决方案，结合质量专业和数字能力，以确保在同时涉及数字化与质量/合规两方面的业务中，符合 PQS、cGMP 等法规要求
- Define site quality improvement which are enabled by digital technologies.
- 利用数字化技术推动工厂的质量提升
- Leading/implement site quality digital transformation strategy and plan, uplifting organization digital capability
- 领导/实施工厂质量团队的数字化转型计划，提升质量团队的数字化能力
- Introduce/implement/support digital use case to achieve the quality improvement.
- 引入/实施/支持数字解决方案以实现在质量领域的改进
- Support the daily affairs of quality-related systems, promote the integration and optimization of systems and related business processes.
- 支持质量相关系统的日常事务，推动系统与相关业务的整合优化
- Improve the visualization of quality business, develop data analysis capabilities, provide support for different quality tiers to make decisions based on data.
- 提升质量业务的可视化水平，开发数据分析能力，为各层级基于数据制定质量决策提供支持
- Build the innovation culture and improve the digital ability of Quality Assurance Function.
- 打造创新文化，提升质量保证团队的数字化能力
- Act as business Quality partner with IT
- 作为IT团队的质量合作伙伴
- Manage Quality Function digital applications to support daily business.
- 管理质量职能团队的数字化应用以支持日常业务
- Take the role as QA business partner to support Digital Uplift in Taizhou Site.
- 作为质量合作伙伴支持泰州工厂的数字化提升项目
- Participate in the develop of quality management strategy for new technology.
- Ensure the projects delivering and related validation activities meet the requirements of GMP regulations and quality requirements.
- 参与制定新技术的质量管理战略。确保项目交付及相关验证活动符合GMP法规和质量要求
- Act as a conduit to take direction from Ops Quality to site in delivering Digital Strategy
- 在交付数字战略的过程中，确保运营质量团队与工厂之间的沟通渠道
Education, Qualifications, Skills, and Experience
- Bachelor’s degree and general experience in pharmaceutical quality, manufacturing, or technical roles.
- 本科及以上学历，具有制药质量、生产制造或技术相关岗位工作经验
- A good knowledge of cGMPs and global GMP requirements, quality systems, and pharmaceutical product/device testing technology and pharmacopeia. Well -developed interpersonal and problem-solving skills.
- 熟悉 cGMP 及全球 GMP 要求，了解质量管理体系、药品/医疗器械检测技术及药典相关要求，具备良好的人际沟通能力和问题解决能力
- Have computerized system related working experience
- 具备计算机化系统相关工作经验
- A basic knowledge of computer validation requirements.
- 了解计算机化系统验证要求
- Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional.
- 具备独立工作能力，同时能够在跨学科、跨职能团队环境中高效协作
- Use both Chinese and English as working language.
- 能够熟练使用中英文作为工作语言
- Excellent oral and written communication skills with the ability to communicate effectively with individuals from all levels of the organization.
- 具备优秀的口头及书面沟通能力，能够与组织内不同层级人员进行有效沟通
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
