Pramod Seetha

Skills

Quality Auditing, Investigation management, validation, Qualification, Risk Management

About

With over 23 years of experience across pharmaceutical Quality Assurance, regulatory compliance, and manufacturing quality, I bring a strong track record of leading Quality organizations, and delivering sustained compliance and operational excellence aligned to quality strategies.
Currently, as Senior Director – Site QA Head, at Biocon, I provide strategic leadership to a multidisciplinary Quality team, ensuring alignment with enterprise objectives through robust governance, KPI-driven performance management, and continuous improvement. I have led and hosted multiple global regulatory inspections and customer audits, including USFDA, EMA, EDQM, and Health Canada, most recently leading a successful USFDA inspection resulting in timely receipt of the EIR.
I have extensive experience acting as a primary Quality leadership contact for global stakeholders, regulatory agencies, and external partners. My background in supplier quality governance, CMO oversight, and risk-based quality management aligns well with GCC operating models and the need for consistent, high-quality support across global Quality teams.
Looking forward a role with Pharma Quality Assurance/Quality Auditor and I am keen to contribute to the global quality strategy while helping shape the future direction of the GCC through strong leadership, collaboration, and continuous improvement.
Kind regards,
Pramod G S