Manoj Badhan

About Manoj Badhan

Experienced, Pharma IT and compliance professional and specialize in Computer System Validation (CSV), GxP compliance, and digital transformation initiatives within regulated environments. With a strong foundation in GAMP® 5 principles, I’m passionate about bridging the gap between emerging technologies like AI/ML and the stringent requirements of pharma and life sciences. I actively contribute to risk-based validation strategies, data integrity frameworks, and governance models that ensure operational excellence and regulatory alignment. Key Areas of Expertise:• Computer System Validation (CSV)• GxP Compliance & Regulatory Standards• AI/ML Governance & Validation• Digital Quality & PharmaTech• Risk-Based Approach to IT Systems• Cross-functional Collaboration & Project DeliveryI believe in compliance by design and strive to make innovation safe, scalable, and audit-ready.

Experience

1. Project Quality and Compliance Manager

   Novartis

   Jan 2025 — Present · Hyderabad, IN

   Manages compliance of the system during its lifecycle, with regards to Regulatory and Novartis Internal Standards. This includes management of all system-related changes (approved documents, system changes from functional acceptance testing onwards). This is performed through document reviews & coordination of various activities including testing, performing Project Tollgates etc.• Provides compliance & risk management guidance for IT projects, including the evaluation and recommendation of technical controls. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements, including creation of SOPs as applicable• Ensure implementation and monitoring of information security, IT compliance, records management and information risk management program in the DDIT, to ensure the integrity, confidentiality and availability of information owned, controlled or processed by the organization• Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.• Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course.• Drive shifting of emphasis from \"final inspections\" to \"in-process reviews and controls\".Contribute to business decisions in the definition and assessment of IT requirements.• Support the development and delivery of training in quality matters. Interface with business and IT partners to ensure Novartis practices are aligned with regulatory expectations and industry best practices.• Supports Audits, Inspections and Assessments performed by internal and external agencies. Evaluates the risks arising from control deficiencies, gaps and facilitates risk mitigation planning

Education

• Savitribai Phule Pune University

  B.SC, Microbiology

  2003 — 2006

• Bilcare Research Acedamy

  Clinical Trial Management, Pharmacovigilance and clinical data management

  2007 — 2008

Skills

• Good Clinical Practice (Gcp)
• Sas
• Regulatory Affairs
• Clinical Trials
• Clinical Data Management
• Medical Writing
• Edc
• Ctms
• Ich-Gcp
• CRO
• Gcp
• Team Management
• Pharmacovigilance
• Clinical Research
• Data Management
• Biotechnology
• Healthcare
• Pharmaceutical Industry
• Drug Safety
• Oncology