Senior Quality Project Leader – QMS & Compliance

Medline; Northfield Township (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

Medline in Illinois is seeking an experienced Quality Project Lead to drive initiatives across the quality organization, collaborating with cross-functional teams and external partners to ensure regulatory compliance and robust quality systems. This role bridges design and manufacturing, supporting strategic improvements and cGMP practices across sites.

You will provide technical leadership during investigations, CAPAs, and continuous improvement efforts, with travel up to 30% and a proven track

Qualifications

• Bachelor's degree required.
• 7+ years in pharmaceutical manufacturing or quality assurance.
• Willingness to travel up to 30% domestically and internationally.

Responsibilities

• Lead quality initiatives across the organization and train affected teams on new procedures.
• Improve the QMS for efficiency and stronger regulatory compliance.
• Lead root cause analyses and plan CAPAs with documented evidence.
• Evaluate Cost of Quality and propose cost-saving projects.
• Provide process guidance across sites and corporate functions.
• Lead risk management using methods like FMEA and risk controls.
• Drive cGMP best practices and training across the network.
• Support inspections readiness and regulatory compliance activities.
• Mentor teams and communicate project status to leadership.

Skills

Project leadership

Quality Management

Regulatory compliance

Risk management

Cross-functional teamwork

Travel up to 30%

Education

Bachelor's degree

Job description

Medline in Illinois is seeking an experienced Quality Project Lead to drive initiatives across the quality organization, collaborating with cross-functional teams and external partners to ensure regulatory compliance and robust quality systems. This role bridges design and manufacturing, supporting strategic improvements and cGMP practices across sites.

You will provide technical leadership during investigations, CAPAs, and continuous improvement efforts, with travel up to 30% and a proven track