Head of Quality Operations & Regulatory Excellence

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

Job summary

Medline Industries, LP is seeking an executive leader to oversee strategic planning for large, complex Quality teams across pharmaceutical sites, ensuring cGMP compliance and optimal product quality.

Responsibilities include directing QA programs, regulatory readiness, risk management, CAPA, and collaboration with Operations, Supply Chain, and Business Leadership to meet quality objectives and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field is typically required.
• 8+ years of experience in pharmaceutical manufacturing with GMP/QSR/ISO compliance.
• 5+ years of management experience in a relevant field.
• Proven track record leading enterprise-wide validation, quality, or technical operations programs.

Responsibilities

• Provide strategic Quality oversight of manufacturing, packaging, testing, and laboratory operations across Medline pharmaceutical sites to ensure cGMP compliance.
• Ensure appropriate product disposition decisions through evaluation of manufacturing, laboratory, and quality data.
• Drive Operational Excellence initiatives focused on quality, compliance, efficiency, and continuous improvement.
• Build partnerships with Operations, Supply Chain, Technical Services, and Business Leadership to meet quality and business objectives.
• Ensure site readiness for regulatory inspections, customer audits, and internal assessments.
• Provide leadership for quality risk management, deviation management, investigations, CAPA execution, and escalation processes.
• Drive a culture of accountability, compliance, and continuous improvement across all pharmaceutical manufacturing operations.
• Provide leadership and expertise in strategy development for applicable organizations; motivate teams and ensure execution.
• Assist Suppliers, manufacturing partners and product managers in QA program development and implementation.
• Advise leadership to ensure QSR compliance across departments as measured by FDA/ISO/internal audits.
• Act as liaison with Executive Leadership of Divisions, Suppliers, Manufacturing, and Operations for quality products and on-time delivery.

Skills

Quality leadership

Pharma manufacturing

QA leadership

Regulatory inspections

Leadership

Regulatory knowledge

Data analysis

Excel

Travel willingness

Education

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

Job description

Medline Industries, LP is seeking an executive leader to oversee strategic planning for large, complex Quality teams across pharmaceutical sites, ensuring cGMP compliance and optimal product quality.

Responsibilities include directing QA programs, regulatory readiness, risk management, CAPA, and collaboration with Operations, Supply Chain, and Business Leadership to meet quality objectives and customer satisfaction.