Digital Quality MES Recipe CVS Lead

India, Hyderabad

Digital Quality, MES/Recipe CSV Lead

Location: Hyderabad

Be part of Lonza’s world-class Quality and Regulatory team. As a Digital Quality Lead, you will drive the global harmonization of MES standards and Master Batch Record (MBR) recipes across our manufacturing network. You will be a key contributor to our Global Capability Center (GCC), providing expert CSV guidance for computerized systems, data products, and AI/ML models to ensure the highest standards of compliance and data integrity.

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 opportunity to work collaboratively across global digital quality and IT workstreams.
• Comprehensive benefits package including medical insurance and wellness programs.
  
  

What you will do

• Standardization & Harmonization: Drive the implementation of Lonza global MES standards and related MBR recipe harmonization across the network through involvement in rollout projects and operational change requests.
• Strategic Planning: Create and maintain validation and implementation plans in alignment with project timelines, budgets, and Lonza’s Quality Management System (QMS).
• Validation Excellence: Ensure qualification and validation documentation for computerized systems, data products, and AI/ML models adhere to Lonza quality standards and regulatory expectations.
• Data Quality Representation: Act as the voice of QA in cross-functional teams, driving the strategy and implementation of data quality standards and compliance across the global network.
• Project Advisory: Serve as the quality expert for data product implementations (data lakes, analytics) and coach project teams on the compliant setup and delivery of AI/ML models.
• MES Expertise: Act as the subject matter expert for MES/eBR/Recipe setup, developing robust strategies for site implementation and operational routine execution.
• Compliance & Inspection: Review and approve technical documentation, risk assessments, and regulatory responses; support audits and inspections by translating regulatory trends into actionable improvements.
• Risk Management: Lead root cause analysis and corrective actions for identified quality gaps; escalate risks and drive continuous process optimization for new tools and systems.
• Stakeholder Interface: Maintain the project CSV deliverables list and act as the primary interface to quality stakeholders, including Digital Quality and IT Quality & Compliance.
  
  

What we are looking for

• Experience: Significant experience in CSV and Digital Quality within a pharmaceutical or biotech environment, with a strong emphasis on MES and Recipe management.
• Education: Degree in Life Sciences, Engineering, Computer Science, or a related field; advanced technical certification is a plus.
• Technical Knowledge: Deep expertise in MES/eBR platforms, data analytics, and emerging technologies (AI/ML); strong understanding of global GMP regulations (FDA, Swissmedic).
• Software Proficiency: Advanced knowledge of computerized system validation tools, data lake architectures, and recipe management systems.
• Soft Skills: Strong leadership and coaching abilities, with a focus on process optimization and driving change across complex global projects.
• Communication: Business fluency in English with the ability to influence cross-functional teams and communicate technical quality standards to diverse audiences.
• Mindset: A forward-thinking quality professional who thrives on innovation and takes personal accountability for data integrity and compliance outcomes.
  
  

About Lonza

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.

Reference: R75673

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