Quality Operations & Compliance Leader

GC America; Illinois; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

401(k) through Fidelity and company 10

Dental insurance with Delta Dental PPO

Employee Assistance Program

Health Savings Account

Company Paid Life Insurance two times

Paid time off, including extra week

Job summary

GC America is seeking an Associate Director of Quality Operations & Compliance to lead the site quality organization, ensuring FDA-regulated manufacturing and testing meet cGMP, USP, and ISO standards. The role drives continuous improvement and develops organizational capability for future growth.

You will oversee QA, QC, batch release, CAPAs, deviations, change controls, and validation activities while partnering with Manufacturing, Regulatory Affairs, Validation, and Engineering to uphold

Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Pharma Sciences, Engineering or related field.
• 10+ years of progressive Quality leadership in FDA-regulated environments.
• Direct experience with FDA inspections, 483 responses, and inspection readiness.
• Experience in dental products, pharmaceuticals, OTC or medical devices preferred.

Responsibilities

• Provide quality leadership for QA, QC, and batch release in a regulated setting.
• Direct CAPA, deviations, investigations and change controls.
• Lead site inspection readiness and host FDA/regulatory inspections.
• Develop and monitor quality metrics, dashboards, and process improvements.
• Collaborate with Manufacturing, Regulatory, Validation, and Supply Chain.
• Support supplier quality management and risk-based decision making.

Skills

Quality leadership

FDA/regulatory compliance

Inspection readiness

Cross-functional leadership

Risk management

Education

Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, Engineering, or related field

Advanced degree preferred

Job description

GC America is seeking an Associate Director of Quality Operations & Compliance to lead the site quality organization, ensuring FDA-regulated manufacturing and testing meet cGMP, USP, and ISO standards. The role drives continuous improvement and develops organizational capability for future growth.

You will oversee QA, QC, batch release, CAPAs, deviations, change controls, and validation activities while partnering with Manufacturing, Regulatory Affairs, Validation, and Engineering to uphold