Senior Director of Quality Systems & Compliance (Pharmaceuticals)

Location: Northfield, Illinois, United States. Travel up to 30% may be required within the state, across the country, and internationally.

Salary: $203,000–$305,000 annually, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide healthcare organization providing branded products and operating across pharmaceutical, medical device, and regulated product environments.

What you will do

• Lead strategic planning, execution, and organizational development for complex Quality teams.
• Direct the development of product specifications for hirify.global-branded products and support suppliers, manufacturing partners, and product managers in implementing quality assurance programs.
• Design, implement, and oversee the Pharmaceutical Quality System across the organization.
• Govern CAPA, document control, change control, management review, field alert reporting, recall management, and complaint-handling processes.
• Lead quality investigations, regulatory inspection readiness, compliance improvements, and quality system remediation.
• Manage multiple departments and managers, including budgeting, hiring, performance management, workforce planning, and policy implementation.

Requirements

• Bachelor’s degree in engineering, science, or a technical field.
• At least 8 years of experience in pharmaceutical design and manufacturing, including design controls, risk management, and QSR, GMP, and ISO compliance.
• At least 5 years of management experience; 8 years of managerial experience is preferred.
• Expertise in CAPA systems, investigations, root cause analysis, quality system remediation, and risk-based quality systems.
• Strong knowledge of FDA, EU GMP, ICH, PIC/S, 21 CFR requirements, and other applicable pharmaceutical regulations.
• Advanced Microsoft Excel skills and the ability to analyze quality data, coordinate concurrent projects, and manage critical deadlines.

Nice to have

• At least 10 years of experience in medical device, pharmaceutical, food, cosmetic, or personal products industries.
• Experience with medical devices, combination products, and drug-device portfolios.

Culture & Benefits

• Competitive total rewards package with health insurance, life and disability coverage, 401(k) contributions, and paid time off.
• Continuing education and training opportunities.
• Employee assistance, employee resource groups, and employee service programs for eligible employees.
• Inclusive workplace focused on belonging, diversity, career growth, and providing resources for effective work.