Executive Lead - Pharmaceutical Quality & Compliance

Medline; Northfield Township (IL); On-site; USD 180,000 - 230,000; Full time

Job summary

Medline is seeking a senior leader to oversee strategic planning for large Quality teams, ensuring quality and compliance across assigned departments. The role drives CAPA, PQS, and regulatory readiness, interfacing with executives, suppliers, and manufacturing partners to ensure product quality and on-time delivery.

The position requires 8+ years in pharma quality with 5+ years management, deep regulatory knowledge, and strong data analysis skills; travel up to 30% is expected.

Qualifications

• Bachelor's degree in Engineering, Science, or Technical Field.
• 8+ years in design/manufacture of pharmaceuticals with QSR/GMP/ISO experience or other regulated industries.
• 5+ years of management experience.
• Experience leading regulatory inspections and transformations.
• Travel up to 30% of the time.

Responsibilities

• Lead strategy for the Quality organization and align with stakeholders.
• Direct 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 per audits.
• Oversee CAPA, document control, change control, and recall management.
• Ensure on-time delivery and customer satisfaction through collaboration with executives.
• Establish and maintain training programs across PQO.
• Manage multiple departments and budget responsibilities.

Skills

Leadership

Strategic planning

Quality systems

CAPA

Regulatory knowledge

FDA compliance

Data analysis

MS Excel

Travel up to 30%

Education

Bachelor's degree

Tools

CAPA systems

Document control

Change control

MS Excel

Job description

Medline is seeking a senior leader to oversee strategic planning for large Quality teams, ensuring quality and compliance across assigned departments. The role drives CAPA, PQS, and regulatory readiness, interfacing with executives, suppliers, and manufacturing partners to ensure product quality and on-time delivery.

The position requires 8+ years in pharma quality with 5+ years management, deep regulatory knowledge, and strong data analysis skills; travel up to 30% is expected.