Senior Quality & Compliance Specialist

Job Summary

NMDP is seeking an experienced professional to oversee quality and regulatory compliance for its computerized systems and digital solutions. The role involves conducting independent audits, evaluating SDLC practices, and ensuring that software governance aligns with regulatory requirements such as 21 CFR Part 11 and GAMP 5. The candidate will work closely with IT, Quality Assurance, and product teams to assess risks, identify compliance gaps, and recommend mitigation strategies. Responsibilities include reviewing software documentation, monitoring data integrity controls, and participating in supplier qualification processes. The specialist will also support investigations of software-related deviations, complaints, CAPAs, and audit findings, providing expert guidance on risk-based compliance practices and ALCOA+ principles. This position requires strong communication skills to influence stakeholders, a solid understanding of quality management systems, and the ability to navigate evolving regulatory expectations in a regulated environment.

Key Responsibilities

• NMDP is seeking an experienced professional to oversee quality and regulatory compliance for its computerized systems and digital solutions. The role involves conducting independent audits, evaluating SDLC practices, and ensuring that software governance aligns with regulatory requirements such as 21 CFR Part 11 and GAMP 5. The candidate will work closely with IT, Quality Assurance, and product teams to assess risks, identify compliance gaps, and recommend mitigation strategies. Responsibilities include reviewing software documentation, monitoring data integrity controls, and participating in supplier qualification processes. The specialist will also support investigations of software-related deviations, complaints, CAPAs, and audit findings, providing expert guidance on risk-based compliance practices and ALCOA+ principles. This position requires strong communication skills to influence stakeholders, a solid understanding of quality management systems, and the ability to navigate evolving regulatory expectations in a regulated environment.

About the Role

This role is ideal for someone who enjoys combining strategy, content, data and execution. You will work with cross-functional teams and contribute directly to the company’s digital growth in Kolkata and surrounding areas.

Job Requirements

• Software Quality Assurance
• Risk Management

Required Skills