QA Project Leader: GMP Compliance & Process Improvement

RXinsider LTD.; Melrose Park (IL); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

Disability coverage

401(k) with company contributions

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a results-driven PMO lead to collaborate with the Sr. Director of Quality Assurance.

You will manage projects supporting GMP compliance, continuous improvement, and the timely investigation closure with effective CAPAs to prevent recurrence. Responsibilities include tracking deliverables, providing progress reports to senior management, and supporting FDA inspections.

Qualifications

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

Responsibilities

• Collaborate with Sr. Director, QA to manage PMO for compliance topics and continuous improvement.
• Oversee evaluation, implementation, and follow-up on quality systems and metrics supporting GMP.
• Review investigations for product quality and implement CAPAs to prevent recurrence.
• Track progress, deliverables, deadlines, and responsibilities with progress reports.
• Support regulatory inspections and audits, acting as necessary to provide information.

Skills

PMO

QA/QC

GMP

Regulatory

Education

Bachelor's degree in science

Job description

Fresenius Kabi in Melrose Park, IL is seeking a results-driven PMO lead to collaborate with the Sr. Director of Quality Assurance.

You will manage projects supporting GMP compliance, continuous improvement, and the timely investigation closure with effective CAPAs to prevent recurrence. Responsibilities include tracking deliverables, providing progress reports to senior management, and supporting FDA inspections.