Chandresh Thakur

About Chandresh Thakur

Quality/Regulatory executive with extensive experience in Quality Operations, Regulatory Affairs, Supply chain operations and strategy, business technology systems, global quality system and Transformations programs. Proven leadership in both line and matrixed organizations, with a strong track record of delivering results in positions of increasing diversity and responsibility. Motivated and dynamic business executive with healthcare experience from small start-ups to large global corporations combined.

Experience

1. Global Head Quality and Regulatory

   飞利浦

   Sep 2021 — Present · Cambridge, MA, US

   Responsible for driving the Global Legal Manufacturer and Quality Management System standardization and consolidation to move Philips to an operating company model. • Drive operational excellence for Q&R transformation programs, integration of new acquisitions, and process standardization across Philips with simplified IT applications.• Established Notified Body footprint optimization to support new Innovation and manufacturing footprint optimizations.• Established Phiplis QnR transformation strategy and compliance• Develop and maintain relationships with all regulatory and compliance agencies. Serve as liaison between the Business Unit, the FDA, and other international regulatory agencies as needed• Lead quality and regulatory due diligence assessments and recommendations for acquisitions and define Quality management system impacts• Provide technical leadership, training and vision on Quality & Regulatory affairs initiatives and mandates, uncovering emerging trends and providing the processes necessary to meet rising expectations.• Review and implement the compliance risk areas to ensure Q&R policies and procedures, regulatory decisions, and regulatory strategies for product registrations are consistent with the requirements of the FDA and other regulators.• Review and implement the international regulations to ensure appropriate decision making, organizational structure, and implications to product acquisitions, sales, and how it impacts the ability to market the business unit’s products globally

Education

• University of Phoenix

  Master of Business Administration, Finance

  2001 — 2003

• Nagpur University

  BE, Electronics and Power Engineering

  1996 — 2000

• California State University, Long Beach

  MS, Electrical

  2005 — 2008