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
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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.
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Highlights:
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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.
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Led business reengineering efforts including quality due-diligence and corporate integration of multiple acquisitions for worldwide consumer healthcare/pharmaceutical companies.
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Created and deployed comprehensive corporate governance policies.
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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.
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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.
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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.
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