QA PMO Lead for GMP Compliance & Process Improvement

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

Job summary

Fresenius Kabi in Melrose Park, IL seeks a Quality Assurance Project Manager to lead the PMO for compliance topics and continuous improvement programs, supporting quality systems, compliance, and efficiency. You will oversee evaluation, implementation, execution, and follow-up on quality systems and metrics in support of GMP compliance and finished-product release.

Responsibilities include coordinating QA and operations projects, tracking progress with clear deliverables and deadlines,

Qualifications

• Bachelor degree in science with at least 3 years QA/QC experience in pharmaceutical or related regulatory industry
• Advanced training or experience in cGMP and preferably GLP, ISO requirements
• Experience supporting regulatory inspections and audits
• Strong project management and data analysis skills

Responsibilities

• Lead PMO activities for compliance and continuous improvement
• Coordinate QA and operations projects with clear deliverables and deadlines
• Prepare progress reports for senior management and escalate barriers
• Support regulatory inspections and provide needed information
• Drive deviations reduction, CAPAs, and batch release improvements

Skills

Project management

QA/QC experience

GMP compliance

cGMP

GLP

ISO requirements

Data analysis

Regulatory inspections

Education

Bachelor degree in science

Job description

Fresenius Kabi in Melrose Park, IL seeks a Quality Assurance Project Manager to lead the PMO for compliance topics and continuous improvement programs, supporting quality systems, compliance, and efficiency. You will oversee evaluation, implementation, execution, and follow-up on quality systems and metrics in support of GMP compliance and finished-product release.

Responsibilities include coordinating QA and operations projects, tracking progress with clear deliverables and deadlines,