• Manage implementation plans for data and data analytics efforts:
o Identify potential data sources for new or existing processes in collaboration with relevant stakeholders
o Drive assigned activities leading to design, development and implementation of analytics associated with quality generation activities and operational metrics
o Identify gaps within data generation lifecycle activities and drive solutions to address those.
• Supporting the Team Lead, Quality Data Operations in ensuring oversight of GCP and Quality analytics (such as quality evidence generation activities and operational metrics) and collaborate with Quality Data Operations Lead to develop associated processes and tools, including relevant platforms and’/or dashboards.
• Continuously review data and associated analytics methods to ensure consistency and efficiency of data use. Identify opportunities to improve and simplify data management processes including data collection, analytical solutions design and implementation.
• Lead operational data maintenance efforts
• Bachelor’s degree or equivalent in computer science, business management or related scientific or quality related field or equivalent combination of education, training and experience
• Strong experience in pharmaceutical industry including a data analysis and reporting related role.
• Awareness of GxP regulatory requirements
Desired: Knowledge of GCP, CSV, pharmacovigilance / drug safety regulatory requirements.
• Good understanding of analysis reporting tools
• Proven experience in data wrangling and visualization tools for visual data analysis
• Demonstrated analytical, problem solving and decision-making skills
• Project management skills
• Effectively formulates strategies, tactics and action plan to achieve results
• Highly effective teamwork and collaboration skills.
• Ability to work effectively in an international multicultural matrix organization.
• Fluency in written and spoken English
• Demonstrated knowledge of product development related global regulatory requirements