Sterility Assurance PMO Lead - Microbiology

301044 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

Paid vacation, holidays and personal 0

Health benefits (medical, dental, and

Employee assistance program

Job summary

Fresenius Kabi USA, LLC seeks a QA/QC Project Manager in Melrose Park, IL to lead quality systems initiatives and continuous improvement efforts supporting GMP compliance and product release.

You will coordinate with QA and operations, drive investigations, implement corrective actions, and report progress to senior management. A strong background in cGMP, SOPs, and risk assessments is required to ensure regulatory readiness.

Qualifications

• Bachelor’s degree in science required.
• 3+ years QA/QC in pharma or regulatory setting.
• Strong knowledge of GMP and GLP requirements.
• Experience authoring SOPs and risk assessments (FMEA).

Responsibilities

• Provide project management for compliance topics and continuous improvement to support GMP compliance and product release.
• Oversee final review of investigations to ensure quality and timely corrective actions.
• Serve as PMO, coordinating QA and operations projects for maximum impact.
• Track progress with clear deliverables, deadlines and responsibilities.
• Support regulatory inspections and audits with information and documentation.

Skills

QA/QC

GMP compliance

Project management

SOPs drafting

Risk assessments

Cross-functional leadership

Aseptic processing

Education

Bachelor's degree in science

Advanced training in cGMP/GLP

Job description

Fresenius Kabi USA, LLC seeks a QA/QC Project Manager in Melrose Park, IL to lead quality systems initiatives and continuous improvement efforts supporting GMP compliance and product release.

You will coordinate with QA and operations, drive investigations, implement corrective actions, and report progress to senior management. A strong background in cGMP, SOPs, and risk assessments is required to ensure regulatory readiness.