Digital Quality, IT Project Quality Manager - MES

Location: Hyderabad
Be part of Lonza’s world-class Quality and Regulatory team. As a Computer Systems Validation (CSV) Specialist focusing on Manufacturing Execution Systems (MES), you will be a key contributor to our Global Capability Center (GCC). You will be responsible for the qualification and validation compliance of computerized systems used for cGMP activities, ensuring the integrity of our digital infrastructure to help bring life-changing therapies to market.
What you will get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Global exposure and the prospect to work collaboratively across global quality workstreams.
Comprehensive perks package including medical insurance and wellness programs.

What you will do
Validation Strategy: Create and maintain validation execution plans in line with project timelines, budgets, and Lonza’s Quality Management System (QMS).
MES Implementation:



Lead the planning and execution of validation deliverables for MES system implementations and related recipe lifecycle management (PharmaSuite, Syncade, MODA-ES).
Quality Representation: Act as the voice of QA in cross-functional teams, driving the strategy, execution, and implementation of CSV standards and Quality Compliance across the Lonza global network.
Testing & Execution: Ensure timely and compliant setup and execution of tests in Lonza’s Test Management System (Kneat); monitor progress in test script creation, execution, and review.
Compliance & Guidance: Ensure compliance with cGMP and regulatory requirements (e.g., Swissmedic, FDA) by providing CSV guidance to project teams and assessing the impact of recent regulatory guidance.
Documentation & Review: Review and approve technical documentation, including CSV protocols, risk assessments, test scripts, and validation summary reports.
Training & Advisory: Ens

📌 Digital Quality, It Project Quality Manager Hyderabad
🏢 Lonza
📍 Hyderabad