QA PMO Leader: GMP & Compliance Excellence

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

Benefits offered by this job

401(k) with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Medical, prescription, dental, vision

Job summary

Fresenius Kabi USA is seeking a QA/QC Project Manager to lead quality systems and continuous improvements in a GMP-regulated environment. You will oversee for deviation reduction, batch release timelines, and CAPA execution while coordinating with QA and operations teams.

The role requires a Bachelor degree in science with 3+ years in pharmaceutical QA/QC, and strong knowledge of cGMP/GLP standards. A robust understanding of regulatory inspections will be beneficial in this on-site position in

Qualifications

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

Responsibilities

• Provide project management for quality systems, compliance, and efficiency aligned with GMP and release of finished product.
• Serve as PMO and coordinate QA and operations project teams for maximum impact.
• Track progress with clear deliverables, deadlines, and responsibilities; provide progress reports and remove barriers.
• Manage projects focusing on compliance or continuous improvement, BRFT, and CRT improvements.
• Review root-cause analyses and implement effective corrective actions and preventative measures.

Skills

Microbiology

Aseptic processing

Contamination control

SOPs & risk assessment

Aseptic simulations

Isolator technology

Cross-functional leadership

GMP compliance

Education

Bachelor degree in science

Job description

Fresenius Kabi USA is seeking a QA/QC Project Manager to lead quality systems and continuous improvements in a GMP-regulated environment. You will oversee for deviation reduction, batch release timelines, and CAPA execution while coordinating with QA and operations teams.

The role requires a Bachelor degree in science with 3+ years in pharmaceutical QA/QC, and strong knowledge of cGMP/GLP standards. A robust understanding of regulatory inspections will be beneficial in this on-site position in