Senior Program Manager – Analytics & AI for Quality Operations

About the role

Senior Data Analytics Lead responsible for operationalizing and supporting Quality/Manufacturing Operations analytics, defining and monitoring KPIs, creating insights through data visualization, and enhancing decision‑making with Artificial Intelligence (AI).

Key responsibilities

• Develop and execute an Analytics/AI strategy across quality Operations and build tools to consolidate and centralize operations data (e.g., CAPA, Nonconformance, Calibrations) for better visibility and decision‑making.
• Lead the Analytics Community of Practice and develop local analytics Subject Matter Experts.
• Support Program Managers, Business Process Owners and Operations leadership in making data‑driven decisions.
• Identify opportunities to improve KPI tracking and ensure alignment with Operations goals and strategy.
• Create dashboards, reports, and visualizations to enhance performance tracking.
• Streamline reporting and analytics processes for greater efficiency.
• Automate routine reporting and data consolidation activities through AI.
• Define, operationalize, and support monitoring of Operations KPIs such as CAPA, Nonconformance, and Calibrations.
• Collaborate with Program Managers, Operations teams, and Business Stakeholders to centralize program data and align with strategic objectives.

Required profile

• Minimum 10+ years experience in highly regulated Quality/Manufacturing environments (FDA Regulated Medical Device/Pharma preferred) with a focus on data analytics, AI, and reporting.
• Proficiency in data analytics and AI tools/strategy – Power BI, Tableau, Power Apps, Data Bricks, Snowflake, Azure, and programming languages (Python, R, SQL).
• Proven track record of automating processes and centralizing data systems.
• Familiarity with ISO 13485, FDA 21 CFR Part 820, and other medical‑device regulatory frameworks.
• Experience leading analytics initiatives or teams and fostering cross‑functional collaboration.
• Proactive identification of data risks and implementation of solutions to maintain data integrity.
• Bachelor’s degree in Data Analytics, Computer Science, Mechanical Engineering, Industrial Engineering or related field; Master’s degree desired.
• Advanced communication skills in English, with ability to explain technical concepts to non‑technical audiences and senior leadership.

Required skills

• Power BI
• Tableau
• Power Apps
• Data Bricks
• Snowflake
• Azure
• Python
• R
• SQL