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Munaga Sathish Babu

@munagasathishbabu

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I lead pharmaceutical quality, regulatory compliance, and inspection readiness across global manufacturing networks.

India

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What I'm looking for

I’m seeking a strategic leadership role in Quality, Corporate Quality Assurance, or QA where I can strengthen quality excellence, regulatory compliance, inspection readiness, and operational efficiency.

I've led quality organizations at Naprod Life Sciences, Akums Drugs & Pharmaceuticals, Jubilant Generics, Gland Pharma, and Trident/Axis Clinicals, overseeing QA/QC, QMS, regulatory compliance, and audit readiness for sterile, oncology, oral, and clinical-research operations.

I’ve led readiness for 30+ global inspections, supported 25+ ANDA/dossier submissions, built enterprise quality metrics and compliance dashboards, and delivered ISO, EU, ANVISA, WHO-GMP, and Health Canada outcomes. I’m pursuing strategic Quality, CQA, or QA leadership roles where I can advance quality excellence and operational efficiency.

Experience

Work history, roles, and key accomplishments

Senior GM & HOD – Quality (QA/QC)

Naprod Life Sciences Pvt Ltd

Aug 2025 - Jul 2026 (11 months)

Oversaw Quality Management System for a plant producing oncology and general products including sterile and oral formulations. Led successful completion of EA-EU, ANVISA, WHO-GMP inspections, ISO 9001 certification, and customer audits.

QMS Regulatory Compliance Audit Management ISO 9001 FDA Inspections ANVISA WHO GMP Ample Logic

Senior GM & HOD – Quality (QA)

Akums Drugs & Pharmaceuticals

May 2023 - Jul 2025 (2 years 2 months)

Oversaw Quality Management System for a plant producing general, cephalosporin, and penicillin formulations including sterile forms. Led successful completion of EU, ZAMRA, Ghana, WHO-GMP inspections, ISO certifications, and around 50 customer audits.

QMS Regulatory Compliance Audit Management ISO 9001 ISO 14001 ISO 45001 FDA Inspections WHO GMP

Director – Corporate Quality Assurance

Jubilant Generics Limited

Feb 2019 - May 2023 (4 years 3 months)

Provided corporate quality oversight and compliance governance for R&D, CRO, CMO, and formulation manufacturing operations. Developed enterprise quality metrics and compliance dashboards for senior management review.

Quality Assurance Compliance Data Integrity Internal Audit Supplier Audits CAPA Quality Metrics

GM - QA (HOD - QA)

Gland Pharma

Feb 2017 - Jan 2019 (1 year 11 months)

Led QA as HOD, supporting audit and compliance, QMS including OOS, Change Controls, and APQR. Managed client meetings, operational meetings, and management review meetings to update compliance status.

QMS OOS Change Control APQR Compliance Client Management Sterile Formulations

Head - QA

Trident/Axis Clinics Limited

May 2004 - Dec 2016 (12 years 7 months)

Led QA for bioequivalence studies and clinical trials, and served on the Global Quality Steering Committee. Established Trident Life Sciences as a green field project for formulation and clinical research.

Quality Assurance QMS Clinical Trials Bioequivalence Regulatory Inspections FDA MHRA ANVISA WHO

Manager-CQA

Dr. Reddy's Laboratories

Nov 1998 - May 2004 (5 years 6 months)

Supported pre-submission audits for ANDA and DMF filings by reviewing data across manufacturing sites. Ensured site preparedness for regulatory inspections and supported 20 dossier filings.

ANDA DMF Regulatory Audits Pre Submission Meetings data review

Officer - QA/QC

Microlab

Jun 1997 - Oct 1997 (4 months)

Supported QMS as part of IPQA team for tablets, capsules, liquid orals, pellets, and inhalers. Participated in regulatory audit and compliance, supporting pre-submission audits, internal audits, and vendor audits.

IPQA QMS Regulatory Audits Internal Audit Supplier Audits Tablet Capsule Liquid