Mark S. Broadley is a highly accomplished senior general management and operations executive with 20+ years of experience in the pharmaceutical and medical device manufacturing sectors. His achievements encompass strategic planning, leadership of multi-million-dollar programs, and the successful execution of large-scale projects. Notably, Mark has consistently improved productivity, profitability, and customer satisfaction while tackling highly competitive business and regulatory landscapes. His expertise includes P&L management, product development, regulatory affairs, marketing, strategic alliances and partnerships, supply chain management, mergers and acquisitions, FDA regulations, GMP compliance, engineering and facility management, project management, capital projects, multi-site management, inspections and audits, Lean practices, operational excellence, technology transfer, facility consolidation, CRM, and VRM.
Mark’s career has been distinguished by a strong track record in driving revenue growth, achieving cost reductions, enhancing operational throughput, and launching new products in challenging, regulated industries. He previously served as the Senior Director of Operations at Charles River Laboratories Cell & Gene Therapy CDMO, where he led day-to-day operations of multi-product Cell and Gene Therapy manufacturing operations during facility and QMS remediation & expansion projects. Prior to that, he was the Director of Regulatory, Engineering and Quality at Idex Health and Science, where he led ISO 13485 QMS Improvement Project & Certification for a fast-tracked diagnostic testing (Covid) product. His other previous roles include serving as an independent consultant at Diverse Consulting Firms, Director of Operations/General Manager at Zimmer Bioment – Biologic, General Manager at Cytosol Laboratories, and more. He holds a Bachelor of Science in Accounting and an MBA in Leadership, both from Nichols College.