Senior Manager, Combination Products & Medical Devices

Location: Onsite in North Chicago, Illinois, United States

Salary: $124,500–$236,500 per year

Company

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

What you will do

• Lead quality assurance and quality control activities for complex, high-volume plant operations involving pharmaceuticals, biologics, packaging, APIs, finished goods, and medical devices.
• Act as the decision-making authority for site quality and regulatory compliance matters.
• Ensure products comply with corporate quality standards and applicable regulatory requirements.
• Manage, organize, train, and supervise a team of quality professionals.
• Provide regulatory and technical guidance to plant departments and other sites.
• Manage the Quality Unit operating budget and communicate with executive leadership on quality initiatives.

Requirements

• Bachelor’s degree in physical or life sciences, pharmacy, or engineering; a master’s degree or PhD is preferred.
• 8+ years of combined experience in manufacturing, QA, QC, or R&D within the pharmaceutical, biologics, medical device, or chemical industry.
• 4+ years of supervisory or technical leadership experience.
• Working knowledge of product and raw-material physical and chemical characteristics.
• Familiarity with statistical quality systems, electronic document management, laboratory information management, quality policies, cGMP, and regulatory requirements.
• Strong people-management, communication, judgment, and cross-functional collaboration skills.

Nice to have

• Certified Quality Engineer certification or formal training in quality engineering or statistics.
• Master’s degree or PhD.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility for long-term incentive programs.
• Work focused on regulatory compliance, product quality, and innovation in healthcare.