Job Title:  EXECUTIVE-AUDITS & COMPLIANCE

Job Summary

About NIIT 

At NIIT, were transforming the way the world learns, for the better. That’s why the worlds best run learning functions across the globe trust us with their learning and talent. Since 1981, we have helped leading companies transform their learning ecosystems while increasing the business value of learning. Our comprehensive, high impact managed learning solutions weave together the best of learning theory, technology, operations, and services to enable a thriving workforce.

NIIT operates in over 40 countries, including the UK, Ireland, France and Germany. Due to rapid expansion in Europe, the company now seeks a new dynamic Business Development Director to significantly increase sales to Fortune 500 companies across Europe.

Website: https://www.niit.com/en/learning-outsourcing/

Link for our LinkedIn page: https://www.linkedin.com/company/niitmts/mycompany/ 

NIIT is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Job overview: 

Plans, conducts, and manages internal, external, vendor, and supplier GxP audits to ensure compliance with FDA guidelines, cGMP expectations, company policies/SOPs, and industry standards. The role leads audit reporting, CAPA oversight, risk assessment, inspection readiness, and continuous improvement across regulated processes, computerized systems, and document control. The incumbent collaborates closely with IT and system owners on validation and Part 11 assessments, mentors junior auditors, and acts as a subject matter expert to guide stakeholders on GxP and quality expectations.

Key responsibilities: 

• Plan, execute, and report internal, external, vendor, and supplier GxP audits; assess compliance against GxP regulations, SOPs, and industry standards.

• Identify compliance gaps, risks, and improvement opportunities; review observations and drive timely CAPA closure.

• Support regulatory inspections, customer audits, and inspection readiness activities; may interface with regulatory agencies in support of inspections.

• Monitor audit metrics, compliance trends, and quality performance indicators; maintain audit documentation and records per QMS requirements.
• Escalate unresolved compliance issues to management and follow through to resolution within required timelines.

Educational Qualification

Bachelor’s degree required (Biological Sciences, Chemistry, Pharmacy, Engineering, or equivalent). Post-graduation is preferred.

Experience

Minimum 5–6 years’ professional pharmaceutical experience in Document Control, Quality Compliance, or Quality Operations preferred.