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.
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Global exposure and the opportunity to work collaboratively across global quality workstreams.
Comprehensive benefits package including medical insurance and wellness programs.
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 new regulatory guidance.
Documentation & Review: Review and approve technical documentation, including CSV protocols, risk assessments, test scripts, and validation summary reports.
Training & Advisory: Ensure project team members are trained on Lonza IT requirements and advise teams on processes, standards, and procedures to follow.
Data Integrity: Uphold data integrity principles in accordance with Lonza policies; proactively evaluate, identify, and escalate risks to the data integrity process.
Audit Support: Support audits, inspections, and process qualification activities, translating regulatory trends into actionable quality improvement projects.
Experience: Proven experience in Computer Systems Validation (CSV) within a pharmaceutical manufacturing environment, with specific expertise in MES systems.
Education: Degree in Life Sciences, Engineering, Computer Science, or a related technical field.
Technical Knowledge: Strong understanding of cGMP, GAMP 5, and regulatory requirements (FDA 21 CFR Part 11, EudraLex Annex 11); experience with PharmaSuite, Syncade, or MODA-ES is highly preferred.
Software Proficiency: Proficient with electronic validation tools (e.g., Kneat) and standard Document Management Systems.
Soft Skills: A proactive problem-solver with strong organizational skills and the ability to escalate issues effectively.
Communication: Business fluency in English with the ability to harmonize standards across Global Quality, IT PMO, and IT CoE teams.
Mindset: A collaborative professional who thrives in a project-based environment and takes personal accountability for quality outcomes.
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion, and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
