Jaclyn Scalone

About Jaclyn Scalone

Purpose-driven leader with 20+ years of experience in the pharmaceutical, med tech, and consumer industries. Expertise in developing, implementing, and managing robust Quality Management Systems (QMS) to ensure compliance with global regulatory standards, including FDA, ISO, and GMP. Proven track record of driving quality improvements, mitigating compliance risks, and leading cross-functional teams to enhance product quality and operational efficiency. Skilled in audits, CAPA management, validation and fostering a culture of continuous improvement. Strong analytical and leadership capabilities with a strategic mindset to align quality objectives with business goals. • Collaborates effectively with management, corporate teams, and operations personnel to align quality and compliance goals with business objectives. • Supports business development by identifying opportunities to enhance quality systems and streamline processes. • Strong team player with a track record of fostering collaboration and driving team success in high-pressure environments. • Experienced in change management, guiding teams through process improvements and regulatory updates to maintain compliance and operational efficiency. • Results-driven professional focused on achieving measurable improvements in product quality, compliance, and customer satisfaction. • Highly adaptable to evolving industry standards and business needs, with a flexible approach to problem-solving and innovation.

Experience

1. Depuy Synthes Loaner Quality Lead

   Johnson & Johnson

   Sep 2025 — Present

   Provides leadership for all aspects of the DePuy Synthes Asset Management, leading change to accomplish the overall business, financial, and quality objectives. Leads the DePuy Synthes Orthopaedic Loaner standard and procedures/instruction related to loaner verification. Provides coaching, guidance and leadership for the Regional Customer Quality Loaner set SMEs. Committed to excellence, supporting all last mile projects that impact our loaner and consignment models, ensuring seamless operations and continuous improvement.

Education

• State University of New York

  BA, Sociology

Skills

• Business Development
• Change Control
• Quality Auditing
• Quality System
• Pharmaceutical Industry
• Fda
• Project Management
• Validation
• Result Oriented
• Quality Assurance
• Gmp
• Software Documentation
• Medical Devices
• Teamwork
• Biotechnology
• Manufacturing
• Packaging
• 21 Cfr Part 11