QA Project Leader: GMP & Continuous Improvement PMO

Fresenius Kabi USA; Melrose Park (IL); 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

Employee assistance program

Health benefits

Job summary

Fresenius Kabi USA seeks an experienced Project Manager (QA) to lead PMO activities supporting quality systems, compliance, and efficiency across the plant. You will oversee investigation reviews, corrective actions, and implementation to prevent recurrence, aligning with GMP expectations.

The role emphasizes coordinating QA and operations projects, improving BRFT and CRT metrics, and supporting FDA inspections. A strong background in cGMP and ISO requirements is preferred.

Qualifications

• Bachelor degree in science with 3+ years QA/QC experience in pharma or related regulatory industry.
• Advanced training or experience in cGMP and preferably GLP, regulatory, and ISO requirements.

Responsibilities

• Serve as a PMO and change agent for QA and operations projects.
• Manage projects independently with QA and operations teams for impact.
• Track progress with clear deliverables, deadlines and responsibilities.
• Provide progress reports and escalate issues needing support.
• Lead projects focused on compliance or continuous improvement/simplification.
• Impact: BRFT improvements, CRT, and deviation reduction.
• Analyze quality/manufacturing data and recommend compliance actions.
• Consolidate quality metrics with QA reporting heads.
• Review root-cause analyses and implement effective corrective actions.
• Support regulatory inspections and provide information as needed.
• Prepare and present progress reports for senior management.
• Identify and resolve emerging issues affecting projects or goals.
• Develop contingency plans and ensure health, safety, and quality compliance.

Skills

QA/QC experience

Project management

Quality systems

Regulatory knowledge

Education

Bachelor degree in science

Job description

Fresenius Kabi USA seeks an experienced Project Manager (QA) to lead PMO activities supporting quality systems, compliance, and efficiency across the plant. You will oversee investigation reviews, corrective actions, and implementation to prevent recurrence, aligning with GMP expectations.

The role emphasizes coordinating QA and operations projects, improving BRFT and CRT metrics, and supporting FDA inspections. A strong background in cGMP and ISO requirements is preferred.