QC Lead – IT Operations (IT QC SME)

Location: Hyderabad, India

Join Lonza's Global IT organization as a QX Lead – IT Operations (IT QC SME), where you will serve as the primary subject matter expert for Quality Control (QC) computerized systems supporting laboratory and quality operations across the organization. In this role, you will ensure that critical QC applications are maintained, enhanced, and operated in compliance with GxP requirements, data integrity principles, and global quality standards, while enabling business continuity and operational excellence.

This is an office-first role. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to work with critical laboratory and quality systems in a global life sciences environment.
• Exposure to quality, laboratory operations, validation, regulatory compliance, and digital transformation initiatives.
• Professional growth through application lifecycle management, continuous improvement programs, and global projects.
• Collaboration with global QC, Quality Assurance, IT, Validation, and Compliance teams.
• A variety of benefits dependent on role and location.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

• Serve as the primary Subject Matter Expert (SME) and technical lead for QC applications, including CDS Empower, Moda EM, WinKQCL, Tiamo, SoftMax Pro, and related laboratory systems.
• Provide Level 3 support, system enhancements, project delivery, and lifecycle management activities for assigned applications.
• Partner with QC, Quality, Validation, and IT stakeholders to ensure laboratory processes are effectively supported through compliant and reliable technology solutions.
• Oversee system configuration, governance, troubleshooting, and operational support to ensure business continuity and regulatory compliance.
• Ensure compliance with GxP requirements, data integrity principles (ALCOA+), 21 CFR Part 11, Annex 11, and internal quality standards across all supported systems.
• Assess, review, and support system upgrades, patches, enhancements, and changes, ensuring risks and compliance impacts are properly evaluated and managed.
• Contribute to the development and execution of the Lonza application roadmap by supporting technology improvements, innovation initiatives, and operational excellence programs.
• Support Computer System Validation (CSV) activities, including review and approval of validation documentation, change controls, periodic reviews, risk assessments, and audit trail reviews.
• Develop, review, and maintain SOPs, work instructions, validation documentation, and operational procedures related to system use and lifecycle management.
• Collaborate with business and technical teams to ensure new and enhanced solutions comply with GMP regulations, validation requirements, and IT security standards.
• Provide training, coaching, and guidance to end users and stakeholders to ensure compliant and effective use of QC applications.
• Support internal audits, customer audits, and regulatory inspections by providing system expertise, documentation, and evidence of compliance.
• Drive continuous improvement initiatives to optimize laboratory and quality processes, improve user experience, strengthen controls, and enhance system performance.
• Stay informed on industry trends, emerging technologies, regulatory expectations, and best practices related to laboratory informatics and quality systems.

• Proven experience supporting and administering Quality Control laboratory systems such as CDS Empower, Moda EM, WinKQCL, Tiamo, SoftMax Pro, or similar regulated applications.
• Strong understanding of laboratory operations, quality control processes, and computerized systems used within pharmaceutical, biotechnology, or life sciences environments.
• Experience providing application support, enhancements, lifecycle management, and project delivery for GxP-regulated systems.
• Strong knowledge of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and data integrity requirements.
• Familiarity with Computer System Validation (CSV), GAMP 5 methodologies, risk-based validation approaches, and system lifecycle management.
• Experience supporting quality processes such as change control, deviations, CAPA, training management, and document control.
• Ability to develop and execute IQ/OQ test protocols, test cases, validation documentation, and compliance-related deliverables.
• Strong analytical and troubleshooting skills with the ability to assess complex technical and compliance-related issues.
• Experience working with cross-functional global teams, external vendors, and regulated business environments.
• Bachelor's degree in Computer Science, Information Technology, Life Sciences, Engineering, or a related discipline, or equivalent professional experience.
• Excellent communication, stakeholder management, documentation, and collaboration skills.
• Business fluency in English.

At Lonza, our people are our greatest strength. Working across sites and functions, our globally connected teams help customers bring life-changing therapies to patients around the world. Our values of Collaboration, Accountability, Excellence, Passion, and Integrity define how we work together and support our commitment to delivering high-quality solutions.

Innovation succeeds when diverse perspectives come together. At Lonza, we are committed to creating an inclusive environment where every employee can contribute, grow, and make a meaningful impact.

Ready to help shape the future of Quality Control technology and compliance at Lonza? Apply now.