GxP Compliance Leader - FDA Readiness & Quality

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

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Health benefits

Employee assistance program

Wellness program

Job summary

Fresenius Kabi USA in Melrose Park, IL seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing and R&D, including global facilities for US imports. Lead global quality and compliance initiatives and prepare for FDA inspections.

Responsibilities include evaluating investigations, remediation of regulatory risks, training staff, mock inspections, and providing guidance during inspections. Requires 8+ years with FDA experience; travel may be required.

Qualifications

• Bachelor’s degree required; advanced degree desirable.
• 8+ years of US-FDA/pharma experience.
• Knowledge of cGMPs, ICH guidelines and regulatory compliance.
• Experience in executing GxP audits or inspections preferred.
• Ability to interact with regulators and senior stakeholders.
• Willingness to travel domestically and internationally.
• Strong analytical and leadership skills.

Responsibilities

• Lead global compliance activities for the pharmaceutical division.
• Evaluate investigations and changes impacting regulatory commitments.
• Identify and remediate plant quality and compliance risks.
• Support plants with gap analysis and compliance plans.
• Lead working groups to implement mitigation actions.
• Prepare sites for upcoming US-FDA inspections; train staff.
• Conduct mock inspections and provide inspection readiness training.
• Participate in FDA inspections and back-office support.
• Monitor new FDA cGMP trends and develop strategies.
• Harmonize cGMP and quality processes; manage global projects.
• Prepare global quality management documents and SOPs.
• Collaborate with corporate quality to achieve strategic goals.
• Communicate findings and risks to management.

Skills

GxP compliance

Regulatory affairs

FDA liaison

Quality assurance

Risk management

Project management

Audits/Inspections

Bilingual English/Spanish

Education

Bachelor's degree

Advanced degree

Job description

Fresenius Kabi USA in Melrose Park, IL seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing and R&D, including global facilities for US imports. Lead global quality and compliance initiatives and prepare for FDA inspections.

Responsibilities include evaluating investigations, remediation of regulatory risks, training staff, mock inspections, and providing guidance during inspections. Requires 8+ years with FDA experience; travel may be required.