QA PMO Lead: Quality Systems & Compliance Innovator

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

Benefits offered by this job

401(k) company contributions

Medical, dental, and vision coverage

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi USA is seeking a Senior QA/PMO professional to manage quality systems projects, drive improvements, and ensure GMP compliance. You will oversee investigations, CAPAs, and deviations while coordinating with QA and operations to improve batch release and process efficiency.

The role emphasizes project leadership, regulatory readiness, and continuous improvement in a manufacturing environment; salary ranges align with market norms for QA leadership roles in Illinois.

Qualifications

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

Responsibilities

• Serve as PMO for QA and operations projects and manage projects independently with QA/operations teams.
• Track progress with clear deliverables, deadlines and responsibilities across multiple QA projects.
• Support regulatory inspections (FDA) and audits by providing information and acting as scribe; prepare progress reports for senior management.

Skills

QA/QC experience

cGMP knowledge

GLP knowledge

ISO knowledge

Education

Bachelor's degree in science

Job description

Fresenius Kabi USA is seeking a Senior QA/PMO professional to manage quality systems projects, drive improvements, and ensure GMP compliance. You will oversee investigations, CAPAs, and deviations while coordinating with QA and operations to improve batch release and process efficiency.

The role emphasizes project leadership, regulatory readiness, and continuous improvement in a manufacturing environment; salary ranges align with market norms for QA leadership roles in Illinois.