QA Program Lead: GMP & Compliance Improvement

Fresenius SE & Co. KGaA; Melrose Park, Northern (IL, KY); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Health benefits (medical, prescription

Dental and vision coverage

Employee assistance program

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL seeks a quality-focused PMO lead to drive GMP compliance and continuous improvement initiatives within QA/QA operations.

You will oversee evaluation, implementation, and follow-up on quality systems, manage deviations, CAPAs, and batch release processes, and report progress to senior management.

Join a dedicated team focused on delivering robust quality, regulatory readiness, and efficient production support.

Qualifications

• Bachelor degree in science with a minimum of 3+ years of progressive challenging QA/QC experience in a pharmaceutical or related regulatory industry.
• Advanced training or experience in cGMP and preferably GLP, legal, and ISO requirements.

Responsibilities

• Lead PMO activities for QA/compliance projects and continuous improvement.
• Coordinate and oversee QA and operations teams to maximize impact.
• Track progress with clear deliverables, deadlines, and responsibilities.
• Support regulatory inspections and enable timely investigations and CAPA closure.

Skills

Project management

QA/QC

Regulatory compliance

cGMP

GLP

ISO requirements

Education

Bachelor degree in science

Job description

Fresenius Kabi in Melrose Park, IL seeks a quality-focused PMO lead to drive GMP compliance and continuous improvement initiatives within QA/QA operations.

You will oversee evaluation, implementation, and follow-up on quality systems, manage deviations, CAPAs, and batch release processes, and report progress to senior management.

Join a dedicated team focused on delivering robust quality, regulatory readiness, and efficient production support.