ACADEMIC QUALIFICATIONS

MSc: Dr. Babasaheb Ambedkar Marathwada University

MBA/PGDM: IIM Calcutta

PROFILE SUMMARY

Senior Business professional with 37 years of industry experience, specializing in quality and regulatory functions within the MedTech (medical devices) and pharmaceutical industries. Key skills include Leadership, Strategy, Quality Management System, MDR 2017, Medical Device Sterilization, Aseptic Processing and Auditing.

CONSULTING EXPERIENCE

2 years

EXPERIENCE HIGHLIGHTS

Johnson &Johnson MedTech (2004-2022)
Director- Regulatory Affairs & Commercial Quality (2020-2022)
 General Manager Business Quality: Johnson & Johnson Medical India (2014 -2020)
 General Manager D&D: R&D J&J APAC: (2009-2014)
 General Manager Quality Operations: ETHICON, J&J: (2003 – 2009)
 General QA Manager: ETHICON, J&J: (1994-2003)

 Provided leadership & strategic direction to the QA & RA team/s to ensure outcomes are in line
with organizations objectives & goals.
 Shaped & improved the organizations Quality Management System to align with International
Harmonized standards such as ISO 13485,
 Ensured adequate understanding of Medical Device regulatory requirements and anticipated the
various changes in the regulatory landscape and its impact on business. Led the transition of the
regulatory regime from D&C Act to MDR 2017 in 2018.
 Provided the Quality System & Regulatory perspective in the Strategic Business Development
plans of the organization.
 Established appropriate connections with regional & global leaders to understand and
benchmark best practices.
 Monitored & remained updated with the regulatory scenario & keep the management informed
about the changes & its impact on the ongoing business.
 Monitored & supported the outcomes of Management Reviews & update the TOP Management
(Regional Directors & Vice President).
 Monitored & remained updated with the regulatory scenario & keep the management informed
about the changes & its impact on the ongoing business.
 Successfully achieved ISO 13485 & ISO 9001 certification for Organizations Manufacturing &
Business Quality Organization
 Recipient of Standards of Leadership Award on multiple occasions

Lupin- Sr ExecutiveSr Executive (1985-1994)
o Analytical Development (Stability Indicating Methods) and TM validations
o Transfer TM’s to QA/QC
o Review compliance of various aspects related to Aseptic area monitoring (Microbiological and Engineering requirements)
o Manage Instrumentation: HPLC, HPTLC, GC and others