摘要
This is an S&O role with a focus on Quality, Compliance, and Processes and the person selected will also represent AQS in Audits and Inspections, which would include preparation, participation and follow-up activities.
About the Role
Major accountabilities:
Operational management of strategic functional initiatives within Advanced Quantitative Sciences (AQS) Provides strategic insights to the internal and external activites/interactions of Advanced Quantitative Sciences (AQS), to define future priorities of the function Identifies process improvements and best practices and supports implementation to ensure quality, consistency, efficiency and a high level of compliance Represents Advanced Quantitative Sciences (AQS), on cross-functional Operational Excellence initiatives Working with relevant process owners, contributes to the creation and update of functional trainings, SOPs, Working Practices, and functional KPIs relevant to Advanced Quantitative Sciences (AQS) Leads Audit readiness activities for Advanced Quantitative Sciences (AQS) (Data Integrity, internal/vendor training compliance, AQWA, inspections, etc.) Drives Business Continuity activities in Advanced Quantitative Sciences (AQS) ensuring optimal preparedness for key roles/systems Contributes to business operations activities within Advanced Quantitative Sciences (AQS) (Town Halls, newsletters, SharePoint governance, etc.) Collaborates with partner functions to support cross-functional operational activities in Advanced Quantitative Sciences (AQS) (Randomization Office, Drug Supply, etc.)
Key performance indicators:
Achieves overall functional goals as defined each year by the Global Head - Advanced Quantitative Sciences (AQS) Ensures high quality, accurate, timely and realistic implementation of strategic functional initiatives and process improvement projects Contributes to a culture of ‘operational excellence’ both within the Advanced Quantitative Sciences (AQS) function and in line with the broader organization Extensive collaboration and effective partnerships within Strategy & Operations and other relevant stakeholders
Minimum Requirements:
Master’s Degree in Quantitative/Life Sciences required Fluent oral and written English Minimum 8 years of relevant pharmaceutical industry experience with an indepth understanding of the drug development process Proven knowledge of statistical processes related to clinical trials and in particular the roles/activities of the Statistician and Pharmacometrician Understanding of the programming environment and data platforms relevant to the Advanced Quantitative Sciences (AQS) function Ability to collaborate successfully with internal and external stakeholders on technical/scientific issues related to Advanced Quantitative Sciences (AQS) Evidence of strategic thinking, scenario evaluation, contingency planning and operational effectiveness/innovation Agility and proven ability to multi-task in an environment with changing priorities Strong project management skills, and ability to adjust to multiple demands within a quantitative team Well organized and results-focused - ability to meet challenging timelines in a dynamic environment Considerable organizational awareness, including significant experience working cross-functionally on issues related to Advanced Quantitative Sciences (AQS) Excellent oral/written communication skills related to technical and scientific issues within
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Business Unit
Innovative Medicines
Company / Legal Entity
CN14 (FCRS = CN014) China Novartis Institutes for BioMedical Research Co., Ltd.
Functional Area
Research & Development
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