Senior GxP Compliance Leader – FDA Readiness & Quality

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

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holidays and personal/g

Health benefits: medical, dental, and

Job summary

Fresenius Kabi USA, LLC is seeking a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing sites and R&D centers, including global facilities for FDA imports. You will lead quality and compliance improvements.

The role requires deep knowledge of cGMPs, cGLPs, and FDA inspections, with 8+ years in pharma regulatory compliance. Travel is required; a bilingual English/Spanish skill is preferred.

Qualifications

• Bachelor's degree required; advanced degree in chemistry, biology, microbiology, or engineering desirable.
• Extensive US-FDA compliance experience in pharma or biotech.
• 8+ years in pharmaceutical industry with regulatory focus.
• Deep knowledge of cGMPs, cGLPs, ICH guidelines and regulatory compliance.
• Experience in executing and/or managing GxP audits or inspections preferred.
• Ability to influence plant personnel and regulators at various levels.
• Willingness and ability to travel domestically and internationally.

Responsibilities

• Lead and coordinate global compliance activities within the pharmaceutical division.
• Evaluate investigations and changes that could affect regulatory commitments.
• Identify and remediate quality and compliance risks through metrics and audits.
• Prepare manufacturing sites and R&D centers for US FDA inspections, including training.
• Perform mock inspections to assess plant readiness for FDA review.
• Support FDA inspections and responses to FDA-483 observations.
• Develop strategies to address new FDA cGMP trends and expectations.
• Harmonize cGMP and quality processes to improve product quality and compliance.
• Prepare global quality management documents (SOPs, guides, work instructions).
• Collaborate with other corporate quality functions and communicate risks to management.

Skills

GxP compliance

US-FDA regulations

FDA inspections

Regulatory strategy

Team leadership

Audits & CAPA

Education

Bachelor's degree

Advanced degree in chemistry/biology/engineering

Job description

Fresenius Kabi USA, LLC is seeking a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing sites and R&D centers, including global facilities for FDA imports. You will lead quality and compliance improvements.

The role requires deep knowledge of cGMPs, cGLPs, and FDA inspections, with 8+ years in pharma regulatory compliance. Travel is required; a bilingual English/Spanish skill is preferred.