Associate Director, Manufacturing Operations (GMP)

Location: Onsite at the Northbridge, Massachusetts facility, United States

Salary: $150,000–$190,207 USD annually

Company

hirify.global is an ophthalmology company developing and commercializing innovative therapeutics to prevent blindness and treat serious retinal diseases.

What you will do

• Lead day-to-day manufacturing operations for commercial and clinical GMP-regulated combination products.
• Develop manufacturing strategies, production forecasts, staffing plans, budgets, and capacity plans.
• Manage and develop manufacturing managers, senior associates, and personnel across multiple shifts.
• Partner with Quality, Engineering, Supply Chain, Regulatory, and Product Development to maintain compliance and operational excellence.
• Oversee investigations, deviations, nonconformances, CAPAs, audits, and regulatory inspection readiness.
• Lead manufacturing readiness for new product introductions, process transfers, scale-up, commercialization, validation, and equipment qualification.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Operations Management, or a related technical discipline.
• 8–12 years of experience in GMP-regulated manufacturing environments, including 3–5 years of progressive manufacturing leadership.
• Experience with combination products, medical devices, pharmaceuticals, biotechnology, or other regulated industries.
• Advanced knowledge of cGMP regulations, FDA requirements, quality systems, manufacturing planning, scheduling, and capacity management.
• Experience leading manufacturing teams through commercial production, scale-up activities, inspections, investigations, CAPAs, and operational improvements.
• Strong people leadership, analytical, organizational, decision-making, communication, and cross-functional collaboration skills.

Nice to have

• Advanced degree such as an MBA or MS.
• Experience supporting regulatory inspections and quality system compliance activities.

Culture & Benefits

• Work in an ophthalmology company focused on preventing blindness and improving patients’ lives.
• Culture centered on transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
• Equal opportunity workplace committed to diversity and inclusion.
• Compensation considers education, training, experience, market conditions, role criticality, and internal equity.