Global FDA GxP Compliance Leader

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 172,000 - 192,000; Full time

Benefits offered by this job

Bonus plan (14%)

401(k) plan

Health benefits

Job summary

Fresenius Kabi USA, LLC seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing sites and R&D centers, including global facilities handling API or finished products for the US market.

The role leads quality and compliance improvements and coordinates regulatory readiness and responses. The position involves audits, training, inspections, and close collaboration with global quality functions to drive consistent cGMP and regulatory standards.

Qualifications

• Bachelor's degree required.
• Advanced degree in chemistry, molecular biology, microbiology or engineering is highly desirable.
• Experience: 8+ years in pharmaceutical industry and US-FDA.
• Knowledge of cGMPs, ICH guidelines and regulatory compliance.
• Experience in GxP audits or inspections preferred.

Responsibilities

• Lead, coordinate, verify and track global compliance activities within the pharmaceutical division.
• Evaluate investigations and changes impacting regulatory commitments.
• Identify and remediate plant quality and compliance risks; lead cross-functional mitigation actions.
• Prepare manufacturing sites and R&D centers for US-FDA inspections, including staff training and mock inspections.
• Support during US-FDA inspections and assist in responding to FDA-483 observations.

Skills

GxP Compliance

US FDA regulations

Regulatory inspections

Quality systems

Audit management

Education

Bachelor's degree

Advanced degree in science/engineering

Job description

Fresenius Kabi USA, LLC seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing sites and R&D centers, including global facilities handling API or finished products for the US market.

The role leads quality and compliance improvements and coordinates regulatory readiness and responses. The position involves audits, training, inspections, and close collaboration with global quality functions to drive consistent cGMP and regulatory standards.