Head of Pharmaceutical Quality & Compliance Strategy

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

Job summary

Medline Industries, LP is seeking a senior Quality leader to oversee strategic planning for large, complex Quality teams and ensure regulatory compliance across products and processes. You will direct QA program development, liaise with executives, and drive PQS design and key quality systems.

The role requires extensive experience in pharmaceutical quality, regulatory knowledge, and a proven ability to manage cross-functional programs with a travel up to 30%.

Qualifications

• Bachelor’s degree required in engineering, science, or technical field.
• 8+ years in design/manufacture of pharmaceuticals with QSR/GMP/ISO exposure.
• 5+ years of management experience.
• Strong CAPA and quality system knowledge.
• Experience with FDA, EU GMP, ICH regulations.
• Willingness to travel up to 30%.

Responsibilities

• Provide leadership and develop strategy for quality organizations; motivate teams and ensure execution.
• Direct and lead teams in developing product specifications for Medline branded products.
• Support Suppliers, manufacturing partners and product managers in QA programs.
• Advise leadership to ensure QSR compliance via audits.
• Act as liaison with executive leadership to ensure quality, on-time delivery and customer satisfaction.
• Design, implement, and oversee the Pharmaceutical Quality System (PQS).
• Own key quality processes: CAPA, Document Control, Change Control, Management Review, Field Alert Reporting, Recall Management.
• Ensure CAPA execution across PQO; serve as CAPA SME.
• Report, investigate, escalate, and close Field Alert Reports per regulators.
• Establish and maintain a training program for PQO personnel.
• Partner with Medline Corporate to ensure complaint handling supports regulatory needs.

Skills

Strategic planning

Leadership

Quality systems

CAPA

Regulatory knowledge

FDA regulations

Data analysis

Project management

MS Excel

Travel up to 30%

Education

Bachelor’s degree in Engineering/Science/Technical Field

Job description

Medline Industries, LP is seeking a senior Quality leader to oversee strategic planning for large, complex Quality teams and ensure regulatory compliance across products and processes. You will direct QA program development, liaise with executives, and drive PQS design and key quality systems.

The role requires extensive experience in pharmaceutical quality, regulatory knowledge, and a proven ability to manage cross-functional programs with a travel up to 30%.