GxP Compliance Lead for FDA Inspections

Fresenius; Melrose Park (IL); Híbrido; USD 172.000 - 192.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) plan with company contributions

Paid vacation, holidays and personal (

Health benefits: medical, prescription

Bonus plan with target 14%

Descripción de la vacante

Fresenius Kabi in the United States seeks a Sr. Manager, GxP Compliance Officer (GCO) to assure US-FDA compliance across manufacturing sites and R&D centers, including global facilities for importation of API or finished products to the US market. This position leads company-wide US-FDA quality and compliance improvement efforts.

Salary Range: $172,000-$192,000 based on experience. Bonus target of 14% and comprehensive benefits including 401(k) with company contributions, paid

Formación

• Bachelor's degree required.
• Advanced degree in chemistry, molecular biology, microbiology or engineering highly desirable.
• Accomplished US-FDA compliance expert.
• Experience: 8+ years in pharmaceutical industry and/or US-FDA.

Responsabilidades

• Lead, coordinate, verify and track global compliance activities within the pharmaceutical division.
• Evaluate investigations and changes affecting regulatory commitments.
• Identify and remediate plant quality and compliance risks; lead working groups to ensure mitigation plans are executed.
• Prepare manufacturing sites and R&D centers for upcoming US-FDA inspections, including training and mock inspections.
• Support FDA inspections (in room and back office) and responses to FDA-483 observations.
• Identify new FDA cGMP trends and develop strategies to meet new expectations.
• Strategically optimize cGMP and quality processes; prepare global quality management documents.
• Collaborate with corporate quality functions on strategic goals and communicate risks to management.

Conocimientos

GxP compliance

FDA inspections

Project management

Quality management systems

Regulatory affairs

Communication skills

Bilingual English/Spanish

Leadership

Analytical problem solving

Travel flexibility

Educación

Bachelor's degree

Advanced degree in chemistry, molecular biology, microbiology or engineering

Herramientas

Audit tools

Descripción del empleo

Fresenius Kabi in the United States seeks a Sr. Manager, GxP Compliance Officer (GCO) to assure US-FDA compliance across manufacturing sites and R&D centers, including global facilities for importation of API or finished products to the US market. This position leads company-wide US-FDA quality and compliance improvement efforts.

Salary Range: $172,000-$192,000 based on experience. Bonus target of 14% and comprehensive benefits including 401(k) with company contributions, paid