eCompliance Manager

Sandoz India; Telangana; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Sandoz is seeking a senior IT Quality & Compliance professional in Telangana, India, to provide QA oversight for CSV and IT qualification activities, ensuring adherence to GxP, 21 CFR Part 11, and data integrity.

The role includes reviewing validation deliverables, guiding global projects, mitigating compliance risks, and collaborating with Quality, IT, Infrastructure, and business units to harmonize practices.

Qualifications

• Experience in regulated IT environments with validation and qualification lifecycle.
• GxP data integrity and compliance with global health authority expectations.
• Knowledge of cloud/SaaS and mobile/digital applications in regulated settings.

Responsibilities

• Provide QA oversight for CSV and IT infrastructure qualification activities.
• Review and approve GxP-impacting changes, deviations, CAPAs, and validation docs.
• Support global projects with guidance on validation and compliance deliverables.
• Assess compliance risks and drive continuous improvement and inspection readiness.
• Collaborate with Quality, IT, Infrastructure and business stakeholders to ensure compliant operations.

Skills

GxP & 21 CFR Part 11

IT Quality & Compliance

SAP/Veeva/MES familiarity

Education

Degree in IT/Life Sciences/Pharmacy/Engineering

Tools

SAP

Veeva

MES

Job description

Major Accountabilities

• Provide Quality Assurance oversight for Computerized Systems Validation (CSV) and IT Infrastructure Qualification activities. Ensure compliance with GxP, 21 CFR Part 11, Annex 11, data integrity requirements, and Sandoz quality standards.
• Review and approve GxP-impacting changes, deviations, CAPAs, periodic reviews, supplier qualification assessments, and validation/qualification documentation.
• Support global projects and operational teams with expert guidance on validation, qualification, and compliance requirements. Review and approve key validation and qualification deliverables for computerized systems and infrastructure projects.
• Assess compliance risks and recommend appropriate mitigation strategies. Drive continuous improvement, inspection readiness, and harmonization of validation and qualification practices across the organization.
• Partner with Quality, IT, Infrastructure, and business stakeholders to ensure compliant implementation and operation of GxP-regulated systems.

Ideal Background

Specific Professional Competencies

• Solid understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements, EMA Annex 11.
• Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)
• Experience with SAP, Veeva, MES is preferable

Education

• Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent:
• Fluency in English (oral and written), additional language(s) a plus

Experience

• 10-15 years of overall IT experience, and a minimum 7 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance.
• Solid experience in the development, implementation, and lifecycle management of computerized systems in regulated environments.
• Experience in quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments.
• Highly experienced in the operational management of GxP solutions including its related technologies to support the operation.
• Experience in the development, implementation, and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, Trackwise, CRM, IAM, etc.).

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people 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 careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz