Manager, Quality (Pharmaceutical Manufacturing)

Location: Round Lake, Illinois, United States

Salary: $112,000–$154,000 annually

Company

hirify.global develops and manufactures healthcare products focused on improving patient care and sustaining lives.

What you will do

• Lead quality assurance for dedicated manufacturing operations in the penicillin area.
• Oversee batch disposition, batch documentation review and approval, deviations, investigations, CAPA, and contamination control.
• Conduct process compliance audits and support internal and external audits.
• Develop and implement quality systems, procedures, policies, and documentation aligned with cGMP, FDA, EU, and PIC/S requirements.
• Manage quality personnel and technicians while coordinating with Manufacturing, Engineering, Microbiology, Supply Chain, and other stakeholders.
• Track quality metrics, lead improvement projects, and drive process efficiency, compliance, and reliable product release.

Requirements

• Must not be allergic to penicillin or cephalosporin drugs.
• Bachelor’s degree in Science, Engineering, or a related discipline.
• At least 3 years of experience in Quality or a related field and at least 1 year of people leadership or supervisory experience.
• Knowledge of cGMP regulations, FDA/EU/PIC/S requirements, and quality systems.
• Experience with batch record review, deviations, investigations, CAPA management, contamination control, and manufacturing compliance.
• Applicants must be authorized to work for an employer in the United States; employment visa sponsorship is not available.

Nice to have

• Experience in pharmaceutical or medical device manufacturing.
• Experience with penicillin, sterile, injectable, or highly potent manufacturing operations.

Culture & Benefits

• Medical, dental, vision, life, disability, and business travel accident insurance.
• Paid time off, paid holidays, paid parental leave, and family and medical leave.
• 401(k) retirement plan with company matching and an employee stock purchase program.
• Tuition reimbursement, educational assistance, flexible spending accounts, commuting benefits, and childcare benefits.
• Collaborative quality organization with opportunities to work in plant and office environments.