Sr. Director of Quality Operations

Responsibilities

• Manage direct reports in Quality Assurance and Quality Control departments at the Ledgewood, NJ site
• Lead day-to-day quality operations to ensure compliance with SOPs, cGMPs, FDA standards, and USP/NF monographs
• Establish quality strategy, priorities, and resource allocation to support manufacturing and supply objectives
• Provide quality oversight for manufacturing, packaging, labeling, validation, and technology transfer
• Sustain perpetual inspection readiness and lead state and federal health/drug authority inspections
• Oversee batch review and release processes for raw materials, components, and finished drug products
• Lead investigations into out-of-specification analytical results and deviations to identify root causes and CAPAs
• Ensure data integrity of all documentation supporting commercially distributed compounded drug products
• Establish and monitor Quality Key Performance Indicators (KPIs)
• Serve as a coach and mentor to the quality unit staff

Requirements

• Bachelor's degree in Science, Engineering, or a related field
• 10+ years of progressive leadership experience within a cGMP facility
• Experience managing or supervising large groups of 20+ employees
• Strong technical understanding of manufacturing, laboratory, and quality systems
• Proven leadership in regulatory inspections and complex quality decision-making
• Proficiency in Microsoft Office Suite and database management
• Ability to travel up to 10%

Preferred Qualifications

• Master's degree
• Experience with aseptic drug product bulk manufacturing processes

About the Company

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio including retina, dry eye disease, and surgical products.