Associate Director, Product Quality (Pharmaceuticals)

Location: North Chicago, Illinois, United States

Salary: $141,500–$268,500 per year

Company

hirify.global develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead quality professionals and cross-functional teams through product transfers, third-party manufacturing activities, and new product launches.
• Develop and implement global product quality assurance strategies for pharmaceuticals, biologics, medical devices, and combination products.
• Act as the primary quality contact between third-party manufacturers, hirify.global operations, R&D, regulatory affairs, and affiliates.
• Make decisions on product quality, compliance, and regulatory conformance, escalating medium- and high-risk events.
• Manage quality and technical agreements, supplier relationships, exceptions, CAPA, audits, due diligence, and inspection readiness.
• Lead division-level quality systems, including SOP development, maintenance, training, and continuous improvement.

Requirements

• Bachelor’s degree in life science or another relevant technical field; a graduate degree is desirable.
• 10+ years of experience in quality assurance operations management, regulatory, operations, or technical support in a pharmaceutical setting.
• Experience with regulatory inspections and direct interaction with regulatory inspectors.
• Strong background in quality assurance or control, manufacturing, laboratory work, technical support, regulatory affairs, or validation.
• Knowledge of pharmaceutical and/or biological technologies, including sterile, liquid, solid, device, and active pharmaceutical ingredient products.
• Experience working with third-party external manufacturing requirements and managing multiple complex priorities.

Culture & Benefits

• Benefits include paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance are available to eligible employees.
• Eligible employees receive access to a 401(k) plan.
• The role participates in short-term incentive programs.
• Work involves collaboration across global plants, affiliates, suppliers, and regulatory organizations.