Global GxP Compliance Leader — FDA-Ready

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

Benefits offered by this job

401(k) plan with company contributions

Health benefits (medical, dental, VSP)

Job summary

Fresenius Kabi seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing sites and R&D centers. Lead global quality initiatives, coordinate investigations, and drive remediation of regulatory risks.

Responsibilities include inspections readiness, training, and supporting FDA interactions. Requires extensive GxP, cGMP, and ICH expertise with strong regulatory communication and travel willingness.

Qualifications

• Bachelor’s degree; advanced degree desirable.
• 8+ years in pharma with US-FDA experience.
• Strong knowledge of cGMP, cGLP, ICH guidelines.
• Experience auditing/inspecting GxP processes.
• Ability to travel domestically and internationally.
• Proven leadership and regulatory communication skills.

Responsibilities

• Lead global compliance activities within the pharma division.
• Evaluate investigations and changes impacting regulatory commitments.
• Identify and remediate quality/compliance risks with metrics and audits.
• Prepare plants for US-FDA inspections and conduct mock inspections.
• Support FDA inspections and respond to 483 observations.
• Develop strategies for new cGMP trends and harmonize processes.
• Create global quality documents and manage strategic quality projects.

Skills

US-FDA compliance

Analytical thinking

Project management

Communication skills

Regulatory liaison

Education

Bachelor’s degree

Advanced degree in chemistry/biology/engineering

Job description

Fresenius Kabi seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing sites and R&D centers. Lead global quality initiatives, coordinate investigations, and drive remediation of regulatory risks.

Responsibilities include inspections readiness, training, and supporting FDA interactions. Requires extensive GxP, cGMP, and ICH expertise with strong regulatory communication and travel willingness.