Senior Director, Quality Systems & Compliance Excellence

Medline Industries, Inc. in; Northfield Township (IL); On-site; USD 203,000 - 305,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP seeks a Senior Director of Quality Systems & Compliance (Project Management) to lead strategic planning for large, complex quality teams and ensure product and process compliance across assigned departments.

The role requires extensive experience in pharmaceutical quality systems, CAPA, regulatory inspections, and cross-functional leadership with the ability to drive improvement, manage budgets, and partner with executives to deliver quality products on time.

Qualifications

• Typically requires a Bachelor's degree in Engineering, Science, or Technical Field.
• At least 8 years of experience related to the design and manufacture of pharmaceuticals, including design controls, risk management, and compliance with QSR/GMP/ISO requirements.
• At least 5 years of management experience.

Responsibilities

• Provide leadership and expertise in strategy development for the organization and manage others to ensure execution.
• Direct and lead teams in developing product specifications for Medline branded products.
• Support QA programs with suppliers, manufacturing partners, and product managers.
• Advise leadership to ensure QSR compliance as measured by FDA/ISO/internal audits.
• Liaise with Executive Leadership to ensure quality products, on-time delivery and customer satisfaction.
• Design, implement, and oversee the Pharmaceutical Quality System (PQS) across the organization.
• Own and govern CAPA, Document Control, Change Control, Management Review, Field Alert Reporting, and Recall Management.
• Ensure timely CAPA execution and reporting of Field Alert Reports per regulatory requirements.
• Establish and maintain training programs to ensure competency and compliance across PQO.
• Partner with Medline Corporate and Division Quality leaders on complaint handling processes.

Skills

Strategic planning

Quality systems

CAPA management

FDA/Regulatory knowledge

Regulatory inspections

Leadership

Risk management

Data analysis

Excel proficiency

Travel up to 30%

Education

Bachelor's degree in Engineering, Science, or Technical Field

Job description

Medline Industries, LP seeks a Senior Director of Quality Systems & Compliance (Project Management) to lead strategic planning for large, complex quality teams and ensure product and process compliance across assigned departments.

The role requires extensive experience in pharmaceutical quality systems, CAPA, regulatory inspections, and cross-functional leadership with the ability to drive improvement, manage budgets, and partner with executives to deliver quality products on time.