Hartesh Juneja

About Hartesh Juneja

Highly-accomplished quality professional with more than 22+ years of extensive experience in Pharmaceuticals and Medical Devices. Proven track record of driving transformational change and implementing high-impact quality initiatives across global organizations. Strong understanding of quality management principles, regulatory requirements, and industry standards (e.g, ISO 13485, cGMP, FDA, CE etc). Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization. Strategic thinker with the ability to translate vision into actionable plans and drive results in a fast-paced, dynamic environment. Strategic Leadership: Lead the development and implementation of a comprehensive global quality strategy aligned with the company\'s overall objectives and growth initiatives. Quality Management System (QMS) Enhancement: Oversee the enhancement and optimization of the Quality Management System to ensure compliance with regulatory requirements and industry best practices. Continuous Improvement: Champion a culture of continuous improvement by identifying opportunities to streamline processes, enhance efficiency, and elevate quality standards throughout the organization. Cross-Functional Collaboration: Collaborate closely with cross-functional teams to integrate quality considerations into product development, manufacturing, supply chain, and customer support processes. Risk Management: Develop and implement robust risk management processes to proactively identify, assess, and mitigate quality-related risks across all aspects of the business. Regulatory Compliance: Ensure compliance with all relevant regulatory standards and requirements governing our products and operations, both domestically and internationally. Quality Metrics and Reporting: Define key quality metrics and establish reporting mechanisms to monitor performance, identify trends, and drive data-driven decision-making. Supplier Quality Management: Partner with supply chain stakeholders to establish and maintain rigorous supplier quality management processes, including supplier qualification, audits, and performance monitoring. Talent Development: Attract, retain, and develop top talent within the quality organization, fostering a culture of excellence, accountability, and continuous learning.

Experience

1. Vice President Global Quality and Regulatory Affairs

   Qmd - Degania I Biometrix I Arthesys

   Aug 2025 — Present

   CORONARY & PERIPERAL VASCULAR PRODUCTS\\\\n\\\\nAngioplasty devices (PTCA) and thrombus aspiration catheters\\\\n\\\\nAngiography and angioplasty accessories\\\\n\\\\nCYGNUS II Cobalt Chromium Stent delivery systems\\\\n\\\\nPTA Catheters\\\\n\\\\nY Connectors & Accessories\\\\n\\\\nSilicone components

Education

• Rajiv Gandhi University of Health Sciences

  Bachelor's in Pharmacy

  1999 — 2003

• Punjab State Technical Education Board

  Diploma in Pharmacy

  1997 — 1999

• Venkateshwara Open University

  EMBA

  2019 — 2020