QA Project Leader: Drive Compliance & Process Improvement

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL seeks a Quality Assurance PMO leader to manage compliance projects and continuous improvement programs supporting GMP goals and finished product release. The role includes overseeing investigations and ensuring timely corrective actions to prevent recurrence.

This position collaborates with QA and operations teams to optimize quality systems, reduce deviations, and improve batch release cycle times while reporting to senior management.

Qualifications

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

Responsibilities

• Provide project management for compliance topics and continuous improvement programs.
• Coordinate and oversee QA and operations projects with clear deliverables and deadlines.
• Prepare progress reports and elevate issues to senior management.
• Support regulatory inspections and audits as needed.
• Participate in investigations, CAPAs, and root-cause analysis to prevent recurrence.
• Contribute to reducing deviations and improving batch release cycle time.

Skills

QA/QC experience

Project management

GMP knowledge

Regulatory compliance

Education

Bachelor degree in science

Job description

Fresenius Kabi USA, LLC in Melrose Park, IL seeks a Quality Assurance PMO leader to manage compliance projects and continuous improvement programs supporting GMP goals and finished product release. The role includes overseeing investigations and ensuring timely corrective actions to prevent recurrence.

This position collaborates with QA and operations teams to optimize quality systems, reduce deviations, and improve batch release cycle times while reporting to senior management.