Jobs at Fresenius Kabi

Manages a complex pharmaceutical remediation program by maintaining integrated project plans, coordinating cross-functional workstreams, tracking deliverables and risks, facilitating governance, and preparing executive status reports. Partners with Quality, Manufacturing, Engineering, Validation, Regulatory Affairs, and Supply Chain teams to drive accountability, resolve dependencies, support audit and inspection readiness, and ensure remediation milestones are completed on schedule.

Leads the IT project portfolio and PMO, overseeing strategic planning, resource allocation, budgeting, governance, compliance, reporting, and project methodologies. Manages PM professionals and compliance resources, drives continuous improvement, maintains PPM tools, tracks KPIs and costs, and supports technology investment decisions. Oversees projects from initiation through completion while developing staff, ensuring adherence to standards, and communicating portfolio performance to business and IT leadership.

Leads QA compliance and continuous improvement projects supporting GMP quality systems and finished-product release. Manages project plans, metrics, CAPAs, deviations, yield and batch-release improvements, root-cause reviews, corrective actions, reporting, and risk escalation. Analyzes quality and manufacturing data, supports FDA inspections and audits, develops contingency plans, and presents progress to senior management.

Leads site-wide aseptic training, personnel qualification, contamination control, and continuous improvement across sterile manufacturing operations. Manages aseptic mentors and training personnel, establishes performance metrics, oversees gowning and media-fill qualification programs, investigates contamination-related events and CAPAs, and supports regulatory inspections. Partners with Production, Quality, Validation, Engineering, and Maintenance to standardize aseptic practices, improve operational performance, maintain compliance, and prepare the facility for new sterile manufacturing lines and products.

Performs routine chemical testing of raw materials, in-process samples, stability samples, and finished products for Quality Control. Documents results according to Good Documentation Practices and cGMP or GLP requirements, maintains project records, updates controlled documents in Documentum, conducts peer data reviews, follows safety and housekeeping procedures, and communicates findings to management and peers.

Leads quality assurance projects focused on pharmaceutical GMP compliance, continuous improvement, deviation and CAPA reduction, batch release efficiency, quality metrics, root-cause analysis, and audit readiness. Provides PMO oversight, coordinates cross-functional teams, reviews investigations and corrective actions, and supports microbiology and sterility assurance activities including contamination control, aseptic processing, media fills, and isolator technology.

Administers customer contracts for medical devices, including pricing, compliance, rebates, reporting, amendments, approvals, and renewals. Collaborates with Commercial, Finance, and Legal teams on contract development and customer requests. Maintains contract records and ERP pricing data, resolves pricing disputes, processes orders and returns, manages deadlines and billing obligations, and supports process improvements. The role is hybrid, requiring onsite work in Lake Zurich, Illinois, three days per week.

Administers customer contracts for medical devices, including pricing, rebates, compliance, amendments, reporting, renewals, and payment terms. Collaborates with Commercial, Finance, and Legal teams, resolves pricing disputes, maintains contract records and ERP master data, processes orders and returns, manages deadlines, and supports process improvements. The role requires strong analytical, organizational, communication, and cross-functional collaboration skills, along with SAP or comparable ERP experience and proficiency in Word and Excel.

Leads the U.S. pharmacovigilance and FDA compliance program across multiple product areas. Oversees adverse-event intake, assessment, reporting, signal management, literature reviews, audits, quality planning, safety agreements, and regulatory readiness. Advises global committees and cross-functional teams on labeling, recalls, and product safety. Manages budgets, develops policies and SOPs, and leads, mentors, and develops a multidisciplinary vigilance organization.

Ensures manufactured products meet defined quality and regulatory standards by establishing quality processes, maintaining quality systems, auditing manufacturing operations, monitoring outputs, and investigating process deviations and finished-goods defects.

Oversees engineering project execution, including design, specifications, scheduling, cost estimation, resource coordination, production, installation, testing, and commissioning. Monitors progress against project plans, resolves operational issues, minimizes delays, and develops required resources. May also establish engineering standards, prepare budgets and forecasts, select materials and equipment, and coordinate project staff and external contractors.

Ensures manufactured materials and products meet defined quality and regulatory standards. Develops quality processes and supporting infrastructure, audits manufacturing operations, monitors outputs, and investigates or reports process deviations and finished-product defects.

Assembles, operates, and monitors aseptic manufacturing equipment according to SOPs and cGMP requirements. Applies aseptic techniques to minimize contamination and uses computerized HMI systems. Also supports data entry, office events and moves, reception or mailroom coverage, office systems and procedures, and coordination with corporate entities, vendors, and suppliers.

Provides strategic and generalist HR support, including employee relations, investigations, policy administration, recruiting, compensation, benefits, compliance reporting, organizational design, performance management, training, HRIS support, payroll coordination, employee engagement, and workers’ compensation oversight. The role partners with managers across the organization and may supervise HR staff. It requires onsite work in Lake Zurich three days weekly, with remote work permitted on remaining days.

Leads U.S. revenue accounting, gross-to-net accounting, IFRS 15 compliance, internal controls, SAP GRC governance, audits, and financial reporting for a multinational life sciences business. Oversees control frameworks across major financial processes, evaluates complex commercial arrangements, improves systems and processes, presents risks and recommendations to executive leadership, and develops revenue accounting and internal controls teams.

Leads end-to-end supply chain strategy and performance across three U.S. pharmaceutical manufacturing plants. Oversees production planning, inventory optimization, replenishment, distribution, S&OP/IBP, supply risk mitigation, launches, analytics, and continuous improvement. Manages plant supply planning teams and collaborates with manufacturing, quality, procurement, finance, commercial, and global supply chain stakeholders. Ensures product availability, GMP compliance, customer service, working capital performance, and profitability.

Manages the U.S. ancillary product portfolio’s commercial performance, including product strategy, positioning, pricing, forecasting, launches, market analysis, and growth initiatives. Partners cross-functionally with Sales, R&D, Regulatory, Quality, Manufacturing, Supply Chain, and Finance to achieve revenue, profit, and market share goals. Supports marketing communications, trade shows, digital channels, customer portals, promotional materials, and financial planning while resolving complex business issues and prioritizing customer and inventory needs.

Supervise manufacturing engineers and provide first-level escalation support for regulated production lines. Lead troubleshooting, continuous improvement, equipment upgrades, technology transfers, deviation investigations, and corrective actions. Ensure equipment remains validated and compliant with cGMP, FDA, OSHA, and environmental regulations. Manage improvement projects, funding requests, contractors, vendors, and cross-functional collaboration while mentoring junior engineers and supporting highly automated pharmaceutical manufacturing operations.

Leads strategic planning, forecasting, budgeting, management reporting, and financial analysis for two business units. Partners with executives to guide growth, profitability, cash flow, productivity, and risk decisions. Oversees corporate reporting packages, improves financial systems and processes, analyzes variances and assumptions, and recommends corrective actions. Manages and develops a team of 3–4 finance professionals through coaching, mentoring, and performance management.

Structures and writes complex technical manuals and documentation. Researches technical data, collaborates with technical staff, reviews terminology and content for accuracy, incorporates updates, and edits materials to improve clarity, flow, readability, and effectiveness for intended audiences.