The Quality Data Operations Specialist executes data analytics efforts in collaboration with Quality Data Operations Lead to enable the best use of data and data analytics supporting PDQ Strategy. The role supports Quality Data Operations Lead in management of operational aspects of data analytics, including creation and maintenance of relevant tools, platforms and dashboards. The role drives relevant data collection and generation activities to enable consistent and efficient use of data across PDQ and within relevant functions.
Primary Responsibilities and Accountabilities:
Data Analytics execution
• 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.
Data operations oversight
• Support TL, 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.
Professional and Technical Requirements
• 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.
• Minimum 3 years in pharmaceutical industry including at least 1 in a data analysis and reporting related role.
• Awareness of GxP regulatory requirements.
• Knowledge of GCP, CSV, pharmacovigilance / drug safety regulatory requirements.
Experience, Skills, Knowledge:
• 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.
• Excellent written and verbal communication skills.
• Fluency in written and spoken English.
• Demonstrated knowledge of product development related global regulatory requirements.
Other (e.g. Travel): Travel: up to 10%