Product Quality Senior Manager (Science) (Pharmaceuticals)

Location: North Chicago, Illinois, United States

Salary: $124,500–$236,500 per year

Company

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

What you will do

• Lead quality assurance and compliance activities for pharmaceutical, biologic, combination, and medical device products.
• Manage quality deliverables, product transfers, organizational optimization, and third-party manufacturing activities.
• Develop and implement global Product Quality Assurance strategies with Regulatory Affairs and other functions.
• Perform final quality release of product lots manufactured by third-party organizations.
• Manage quality agreements, regulatory conformance issues, audits, due diligence, and inspection readiness.
• Support product launches, investigations, corrective and preventive actions, management reviews, and product quality reporting.

Requirements

• Bachelor’s degree in life science, engineering, or another relevant technical discipline.
• At least 8 years of combined experience, including 3 years in Quality Assurance Operations Management.
• Strong background in quality assurance or control, manufacturing, laboratory, technical support, regulatory affairs, or validation.
• Experience with FDA and other regulatory agency interactions and inspections.
• Knowledge of pharmaceutical and biological technologies, including sterile, liquid, solid, device, and active pharmaceutical ingredient products.
• Strong analytical, problem-solving, leadership, communication, and multitasking skills.

Culture & Benefits

• Paid time off, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.