QA PMO Leader – GMP Compliance & Process Improvement

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

401(k) with company contributions

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a Quality Assurance/PMO program leader to provide project management for compliance topics and continuous improvement across quality systems. You will oversee evaluation, implementation, and follow‑up on GMP compliance, investigations, and corrective actions to prevent recurrence.

The role reports to the Sr. Director, Quality Assurance and supports short- and long-term goals for quality, compliance, and efficiency in a manufacturing environment.

Qualifications

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

Responsibilities

• Serve as a change agent performing project management duties (PMO).
• Manage projects independently while coordinating QA and operations teams.
• Track progress with clear deliverables, deadlines and responsibilities.
• Provide progress reports and escalate issues as needed.
• Lead projects focused on compliance or continuous improvement/simplification.
• Improve deviation reduction, BRFT and CRT in the plant.
• Reduce rejects, improve yield and manage CAPAs projects.
• Analyze quality/manufacturing data and recommend improvements.
• Consolidate quality metrics with QA heads.
• Review root-cause analyses and implement effective CAPAs.

Skills

Project management

QA/QC

Regulatory compliance

Education

Bachelor degree in science

Job description

Fresenius Kabi USA, LLC is seeking a Quality Assurance/PMO program leader to provide project management for compliance topics and continuous improvement across quality systems. You will oversee evaluation, implementation, and follow‑up on GMP compliance, investigations, and corrective actions to prevent recurrence.

The role reports to the Sr. Director, Quality Assurance and supports short- and long-term goals for quality, compliance, and efficiency in a manufacturing environment.