Senior GxP Compliance Lead — FDA Readiness & Global Quality

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

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holiday and personal D

Health benefits: medical, prescription

Dental and vision coverage

Employee assistance program

Job summary

Fresenius Kabi USA seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliant operations across manufacturing sites and R&D centers, coordinating global quality and compliance efforts for US-market imports.

The role oversees inspections readiness, investigations, CAPA, and risk management, aligning cGMP and related processes. Requires a bachelor’s degree and 8+ years in pharma with US-FDA experience; willingness to travel is expected.

Qualifications

• Minimum of Bachelor’s degree required.
• Advanced degree in chemistry, molecular biology, microbiology or engineering highly desirable.
• 8+ years experience in pharmaceutical industry and/or US-FDA.
• Strong knowledge of cGMPs, ICH guidelines and regulatory compliance.
• Experience in executing and/or managing GxP audits or inspections.
• Ability to travel frequently (domestic and international).

Responsibilities

• Lead global compliance activities within the pharmaceutical division.
• Evaluation of Investigations and Changes that could have an impact on regulatory commitments.
• Identification and remediation of plant quality and compliance risks through evaluation of tradition and non-tradition metrics, audit results, gap assessments, etc
• Support plant on strategy and compliance plans for identified gaps
• Lead/manage working groups to ensure mitigation plans are executed
• Responsible for specific preparation of manufacturing sites and R&D Centers for upcoming US-FDA inspections, including but not limited to:
• Training of plant staff for general inspection aspects and behaviors, as well as specific training for subject matter experts
• Performance of mock inspections to evaluate the plants readiness for FDA inspection
• Design and deliver need-based training to specific plants in response to identified gaps
• Direct participation and support during US-FDA inspections (inspection room and back office), including:
• Immediate guidance and support during inspections
• Support and guidance in preparing response to FDA-483 observations
• Independent review of Effectiveness of assigned FDA-483 CAPA
• May also include inspections by local authorities when related to Mutual Recogition agreements
• Responsible for identification of newFDA cGMP trends and development of strategies to fulfill new expectations
• Strategic optimization and harmonization of cGMP and quality related processes to continuously improve pharmaceutical quality and compliance of Fresenius Kabi products
• Preparation of global quality management documents (e.g. SOPs, guiding documents, working instructions)
• Contribution, execution and management of global projects
• Collaborate with other corporate quality functions on the execution of strategic goals
• Communicate findings and risks to plant management as well as senior quality management
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Skills

US-FDA compliance

Quality management

Regulatory affairs

Project management

Education

Bachelor’s degree

Advanced degree in chemistry, molecular biology, microbiology or engineering

Job description

Fresenius Kabi USA seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliant operations across manufacturing sites and R&D centers, coordinating global quality and compliance efforts for US-market imports.

The role oversees inspections readiness, investigations, CAPA, and risk management, aligning cGMP and related processes. Requires a bachelor’s degree and 8+ years in pharma with US-FDA experience; willingness to travel is expected.