Pradeep Pradeep Setty Kumar B

About Pradeep Pradeep Setty Kumar B

Quality is not a checkbox—it’s a culture shaped by integrity, driven by science, and sustained by accountability.”With polymath nature and 14 years of deep-rooted experience in GMP, GLP, and GCP-regulated environments, I bring a proven record of excellence across Clinical Auditing QA, Pharmacovigilance QA, Data Integrity, quality auditing and complianceand CSV/CSA. At Biocon, I currently serve as Lead – Clinical Auditing QA, PV QA & Quality DI Auditor, steering global audits across 16 CROs, spanning Jordan, China, and the UAE, and enabling regulatory readiness for USFDA, MHRA, EMA, TGA, and other key regulatoryagencies.I’ve led critical initiatives such as establishing a cross-site Data Integrity Office within 30 days, mentoring over 117 DI champions, and launching governance programs like “DI-Bio Connect.” My Six Sigma Green Belt project reduced document turnaround times to 48–72 hours, improving compliance timelines. Awards like “Star of the Quarter,” “Compliant Target Achiever,” and key contributions to Biocon’s \"Quality Culture Transformation\" recognition reflect my dedication to sustainable quality systems and operational excellence.Beyond audits and compliance, I have driven enterprise-wide QMS, conducted 25+ data integrity training sessions, managed SAP-based LMS across 14 facilities, and implemented CSA-compliant CSV validations for e-APQR and GAMP 5 systems. My strength lies in leading cross-functional teams through regulatory transitions and embedding a compliance-first mindset across functions through structured quality culture programs and adult learning frameworks.From sterile injectable QA to managing complex OSD tech transfers, my career has consistently blended microbiological depth, audit leadership, and regulatory strategy. With hands-on exposure to 5 USFDA and 1 MHRA audits and a track record in closing 13 high-impact projects, I seek to collaborate with organizations focused on quality innovation, global compliance, and ethical growth.

Experience

1. Deputy Manager - Cqa Lead Gcp, Gmp and Di Auditor Compliance Qa, Csa, Qms, Pv

   Biocon

   Jul 2025 — Present · Bengaluru, IN

   Auditing BA/BE & clinical studies, qualifying CROs, conducting data integrity audits across sites, and driving CSA-compliant systems while collaborating on QMS and regulatory alignment in Clinical and PV QA functions-Executed 5–6 audits monthly for clinical and BA/BE studies, aligned with ICH GCP E6 and protocol standards-Conducted risk-based six-system DI audits across Biocon Limited and Biocon Pharma Limited locations-Handled clinical and PV CRO qualifications, covering a portfolio of 16 global vendors including in UAE, China, and Jordan-Coordinated QA oversight for injectable drug-device combinations and complex OSD-based clinical trials-Strengthened communication between sponsor and CRO to ensure timely closure of findings and audit observations-Enabled audit readiness by aligning QMS, SOPs, and compliance documentation across CQA and CPQ teams.Key Skills: Clinical Quality Auditing, Pharmacovigilance QA, Data Integrity Audits, BA/BE Study Oversight, CRO Qualification, CSA Compliance

Education

• Manipal Academy of Higher Education

  Master of Business Administration - MBA, Business Analytics

• JAIN College

  Bachelor of Biotechnology, Industrial Biotechnology and Molecular Technics

  2005 — 2008

• Manipal Academy of Higher Education

  Master's degree, Medical Pharmacology

  2008 — 2012

• Manipal Institute of Management, MAHE, Manipal

  Master of Business Administration - MBA, Business Analytics

• Kishore Vidya Bhavan

  SSLC, Biology/Biological Sciences, General

  1990 — 2004