Company
R&DQualityManager
Neural analysis suggests this role is
optimal for Mid+ candidates.
“R&D Quality Manager. Skills: Risk management, Quality management, Health authority, Audit management, CAPA knowledge, Impact skills, Analytical development, Audit, Change control, QA, Quality management, Root cause analysis (RCA), Six Sigma, SOP, Agile, Business cooperation, Self awareness, Continuous learning, Technical expertise. Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable reg”
What You'll Achieve.
Cluster quality system in place and continuously updated as needed; Proactively identify and effectively mitigate risks; Number and severity of issues found during internal and external audits.; Demonstration/recognition leader for specific GxP; early external/industry engagement; Sufficient financial knowledge (e.g., cost management, budget forecasting, etc.); Role model of Novartis culture, values, and behaviors
Industry & Context.
Problem Solving Skills; Root cause analysis (RCA)
What They're Looking For.
Must Have
GxP regulations, Novartis procedures and quality standards, regulatory requirements
Nice to Have
Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge
What You'll Do.
Provide quality assurance expertise
guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards.
including Quality Plan initiatives
and processes that support quality objectives to assure their compliance with GxP regulations.
Support maintenance of regulatory requirement documentation for health authority inspections and assist in health authority inspection management.
Support the development of quality plans for clinical projects (and review other plans for quality/safety aspects).
Support plans to maintain or improve the quality performance and compliance of operational activities
including risk management
health authority reporting
Support initiatives focused on quality
and compliance improvement
including identifying opportunities and developing strategies aimed at enhancing quality while ensuring compliance with regulatory requirements.
Ensure assessment of information obtained during quality and compliance planning and audit and assessment results to determine any regulatory
and QA training needs.
Assist in identifying quality issues and assist in root cause investigations
and support the development of corrective and preventive actions (CAPA)
including monitoring status to ensure issues are resolved
completed and documented.
Provide assistance in correcting deviations
ensuring follow-up and monitoring of related corrective and preventive actions.
Manage and support the quality aspects of projects and activities
including those related to third parties
analytical instruments
manufacturing equipment
Review and approve quality deliverables to ensure compliance (including procedures
clinical trial materials
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Business cooperation
Communication Scope
Communication Skills
Process & Methodology
Project management, Quality Plan initiatives, Manage projects
Full Job Description
**Band** Level 4 **Job Description Summary** -Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. -Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations. **Job Description** Major Accountabilities ~ 支持维护卫生当局检查所需的法规要求文件，并协助卫生当局检查管理 ~ 支持为临床项目制定质量计划（并审查质量/安全方面的其他计划） ~ 支持维持或提高运营活动的质量绩效和合规性的计划，包括风险管理，卫生当局报告，IT系统 ~ 支持专注于质量、流程和合规性改进的举措，包括识别机会和制定旨在提高质量的策略，同时确保符合法规要求 ~ 确保评估在质量和合规性计划期间获得的信息以及审计和评估结果，以确定任何法规，合规性和QA培训需求 ~ 协助识别质量问题并协助根本原因调查，并支持制定纠正和预防措施（CAPA），包括监控状态以确保问题得到解决，完成和记录。 ~ 在纠正偏差方面提供帮助，确保跟进和监控相关的纠正和预防措施。 ~ 管理和支持项目和活动的质量方面，包括与第三方，分析仪器，制造设备，质量计划，培训，IT验证等相关的项目和活动。 ~ 审查和批准质量可交付成果以确保合规性（包括程序，记录，第三方工作，承包商，临床试验材料，组件，差距评估） Key Performance Indicators ~集群质量体系到位并根据需要不断更新 主动识别并有效缓解风险 ~内部和外部审核期间发现的问题数量和严重性。 ~特定GxP的示范/认可领导者;早期外部/行业参与 ~足够的财务知识（如成本管理、预算预测等） ~诺华文化、价值观和行为的榜样 Work Experience ~跨界协作 ~职能广度 ~项目管理 ~关键谈判 Skills ~风险管理 ~质量管理 ~卫生当局 ~审计管理 ~卡帕知识 ~影响技能 ~分析开发 ~审计 ~变更控制 ~QA（质量保证） ~质量管理 ~根本原因分析 （RCA） ~六西格玛 ~SOP（标准操作程序） ~敏捷 ~业务合作 ~自我意识 ~持续学习 ~技术专长 Language 英语 **Skills Desired** Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge
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