Business Analyst Quality Control Solutions- Setlab

Sandoz; India; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Sandoz is seeking an experienced Business Analyst for Quality Control Solutions (Setlab) to join the Manufacturing & Quality Technology organization. You will analyze business processes, define system requirements, and drive implementation and continuous improvement of QC laboratory solutions (LIMS, CDS, LabX) while ensuring GxP and CSV compliance.

You will collaborate with global QC, Manufacturing, and Technology teams to deliver data-driven solutions that enhance efficiency and enable business

Qualifications

• Minimum 5 years of experience in manufacturing, life sciences, pharmaceutical or process industries with a focus on digital technologies and process improvement.
• Experience with Quality Control systems such as LIMS, CDS, LabX or other laboratory informatics platforms.
• At least 3 years delivering Quality IT or laboratory systems projects in a regulated pharmaceutical environment.
• Strong knowledge of CSV, GxP regulations, and quality management processes.
• Demonstrated expertise in requirements gathering, process mapping, and solution design.
• Experience engaging with senior stakeholders in global, matrix organisations.
• Excellent communication, analytical, and influencing skills to translate technical concepts to business language.
• Solid understanding of IT service lifecycle management, testing, validation, and change management.

Responsibilities

• Act as a trusted advisor to global QC and Manufacturing stakeholders to identify opportunities for process and system improvements.
• Gather and translate QC business requirements into global system requirements aligned with digital quality initiatives.
• Lead and support QC system implementation, enhancement, and rollout across lab and quality platforms.
• Collaborate with business and tech teams to assess current processes and design future-state solutions.
• Author and maintain URS with traceability to validation activities.
• Support CSV, testing, qualification activities, and regulatory requirements for lab applications.
• Develop reports and analyze performance data to drive operational efficiency.
• Contribute to QC technology strategy and continuous improvement while ensuring compliance.

Skills

Business analysis

Requirements gathering

Process mapping

Stakeholder management

Analytical thinking

Communication skills

Influencing

Problem-solving

Tools

LIMS

CDS

LabX

Job description

Job Description Summary

We are seeking an experienced Business Analyst Quality Control Solutions - Setlab to join the Manufacturing & Quality Technology organization and play a key role in delivering Sandoz’s Digital Quality Strategy. In this role, you will partner with global Quality Control, Manufacturing, and Technology stakeholders to analyse business processes, define system requirements, and drive the implementation and continuous improvement of QC laboratory solutions, including LIMS, CDS, LabX, and related platforms. You will lead requirements gathering, process modelling, system validation, and deployment activities while ensuring compliance with GxP, CSV, and regulatory standards. The successful candidate will combine strong business analysis capabilities with deep knowledge of quality and laboratory systems to deliver innovative, data-driven solutions that enhance operational efficiency, support global quality processes, and enable business transformation across a highly regulated pharmaceutical environment.

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally.

Job Summary:

We are seeking an experienced Business Analyst Quality Control Solutions - Setlab to join the Manufacturing & Quality Technology organization and play a key role in delivering Sandoz’s Digital Quality Strategy. In this role, you will partner with global Quality Control, Manufacturing, and Technology stakeholders to analyse business processes, define system requirements, and drive the implementation and continuous improvement of QC laboratory solutions, including LIMS, CDS, LabX, and related platforms. You will lead requirements gathering, process modelling, system validation, and deployment activities while ensuring compliance with GxP, CSV, and regulatory standards. The successful candidate will combine strong business analysis capabilities with deep knowledge of quality and laboratory systems to deliver innovative, data-driven solutions that enhance operational efficiency, support global quality processes, and enable business transformation across a highly regulated pharmaceutical environment.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Act as a trusted advisor to global Quality Control (QC) and Manufacturing stakeholders, identifying opportunities to improve processes, systems, and services through data-driven analysis.
• Gather, analyse, and translate Quality Control business requirements into global system requirements, ensuring alignment with business objectives and digital quality initiatives.
• Lead and support global QC system implementation, enhancement, and rollout projects across laboratory and quality management platforms.
• Collaborate with business and technology teams to assess current processes, design future-state solutions, and drive adoption of best practices.
• Author and maintain user requirement specifications (URS), ensuring traceability between business requirements, functional specifications, testing, and validation activities.
• Support computerized system validation (CSV), testing, qualification activities, and GxP compliance requirements for laboratory applications and QC systems.
• Develop reports, analyse system and project performance data, and provide actionable recommendations to improve operational efficiency and business value.
• Contribute to the QC technology strategy, roadmap, and continuous improvement initiatives while ensuring compliance with quality, security, and regulatory standards.

What you’ll bring to the role:

Essential Requirements:

• Minimum 5 years of experience in manufacturing, life sciences, pharmaceutical, or process industry environments, with a strong focus on digital technologies and business process improvement.
• Proven experience working with Quality Control systems such as LIMS, CDS, LabX, or other laboratory informatics platforms.
• At least 3 years of experience delivering Quality IT or laboratory systems projects within a regulated pharmaceutical environment.
• Strong knowledge of Computerized System Validation (CSV), GxP regulations, and quality management processes.
• Demonstrated expertise in business analysis, requirements gathering, process mapping, and solution design.
• Experience engaging with senior stakeholders and managing cross-functional collaboration in global, matrix organisations.
• Strong analytical, problem-solving, communication, and influencing skills with the ability to translate complex technical concepts into business language.
• Solid understanding of IT service lifecycle management, system implementation methodologies, testing, validation, and change management practices.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

Skills Desired

Budget Management, Business Acumen, Performance Management, Planning, Risk Management, Service Delivery Management, Stakeholder Management, Waterfall Project Management