Damodharan M

Chief Quality Officer- Global Quality & Regulatory

Sai Life Sciences

01.2014 - Current

Overall responsibility of Quality system implementation, monitoring & compliance across organization.
Ensure all time readiness and leading all customer and regulatory audits
Face of the organization for communication with FDA, Notified Bodies, and other regulatory agencies for regulatory filings
Rich experience in handling 40+ health authority inspection (USFDA, EDQM, PMDA, TGA etc). i.e. Inspection plan, departmental collaboration, deep shop floor engagement, training, and successful execution as well as 500+ Customer Inspections like GSK, AbbVie, Bayer, Pfizer, J&J, AstraZeneca, Novartis, Roche, Taiho, BMS, Merk, Boehringer Ingelheim, Dia-Chi, Eli Lilly etc.
Expertism in building robust Investigation mechanism with cross functional teams especially for market complaints and product recalls including customer negotiations.
Inspection of external vendors across globe part of Qualification process.
As a Global Quality & Regulatory Head, connecting the strategic and operational challenges across inter units as well as cross-organizational groups globally.
Developed and implemented a strategic vision and mission consistent with Corporate Objectives and industry-leading Quality, Regulatory, and Compliance with the goal strategic vision by simplifying the business processes to reach organization goals/objectives.
Knowledge management process introduced to motivate the workforce towards knowledge enhancement.
Building the strategy Integrity as integral part of quality system and organization goal.
Vast experience in implementing/applying the Analytical strategies part of Inspection preparedness.
Designed a new concept Early phase GMP for development molecules and presented to USFDA.
In-depth research on understanding Human Errors and implementation of practical systems to reduce Human Errors.
Led Data Integrity Awareness in operations and transformed into open / transparent culture.
Established Digitization & Digitalization & Digital Transformation strategy in the organization by building electronic systems throughout Product Development Life Cycle.
Major implementation of electronic systems includes GMP PRO, Learning Management System (LMS), LIMS and adopting CSA approach for Computer System Validations.