Global Pharmaceutical Executive with Expertise in Quality and Compliance Strategies

AREAS OF EXPERTISE

Quality and Compliance

Regulatory Affairs

Strategic Product Design and Development

Supply Chain Management

Governance

Business Reengineering

Technology Platforms

Commercialization Strategies

Mergers and Acquisitions

EXPERIENCE

xCell Strategic Consulting – Principal

Endo Health Solutions, Inc. – Sr. Vice President, Enterprise Quality

Johnson & Johnson – Consumer Groups
-Vice President, Global Quality Assurance
-Vice President, Quality Assurance
-Worldwide Director, Quality Assurance
-Director, Quality Services
-Director, QA and Technical Services
-Manager, Technical Services

Proper-Chem Ltd. – General Manager

ASSOCIATIONS

Past Member, Malcolm Baldridge Board of Examiners

Past Chairman, Food, Drug and Cosmetic Division of American Society for Quality Control

EDUCATION

MS, Management, Polytechnic Institute of Brooklyn, NY

BS, Chemical Engineering, Michigan Technological University


 

 

 

 

Santosh Jiwrajka, Principal

Santosh has over 30 years of experience leading quality and compliance functions in global companies covering pharmaceuticals, medical devices and personal care products. His global responsibilities have covered a large pool of internal plants, external manufacturers and marketing companies. He has a reputation of successfully working seamlessly at both the executive level and the technical project level. He has a strong track record of enabling business growth through successful regulatory compliance outcomes, building organization and leadership pipelines, developing quality systems, integrating diverse businesses and enabling robust and efficient supply chain operations.

Highlights:

  • Reporting directly to the CEO, led quality and compliance functions for a multi-division pharmaceutical (branded and generic) and device company with global sales of $2.5 billion per year.
  • Led business reengineering efforts including quality due-diligence and corporate integration of multiple acquisitions for worldwide consumer healthcare/pharmaceutical companies.
  • Created and deployed comprehensive corporate governance policies.
  • Managed all product categories including NDA and Monographed drugs, medical devices and personal care products for a global consumer healthcare company with a sales scope of $13 billion. Responsible for a large pool of marketing companies, plants and external manufacturers with overall end-to-end QA strategies covering product development, supply chain and commercialization.
  • Executed a global QA management model within a decentralized environment and created a global quality council to link all quality units for major consumer healthcare businesses.
  • Conceptualized, designed and globally deployed three business processes for a multi-national company. These processes were worldwide standardized operating requirements for ten key quality systems/policies; deployment of a single global technology platform to create global visibility and effective change control for specifications; and launch of a single software platform to achieve reliability for the management of nonconformance, CAPA and supplier oversight.