Site Head - Production

Position: Site Head (Sr. Manager) - Production

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About Fresenius Kabi

At Fresenius Kabi, we are driven by a commitment to improve the quality of lives: We are Committed to life. We strive for continuous innovation with our outstanding manufacturing capabilities, unique channel access, and customer proximity.

With our four complementary business areas BioPharma, Pharma (primarily IV drugs and infusion therapy), Medical Nutrition, and MedTech; Fresenius Kabi plays a vital role in the treatment of chronically and critically ill patients across various healthcare settings. For instance, over 70% of our IV drug units shipped in the US are on the Essential Medicines List of the US Food and Drug Administration, emphasizing the importance and impact of our products.

All meaningful care comes down to people with the experience, expertise, and compassion to make a difference in the lives of those facing challenging situations. For us, care is a fundamental obligation, mission, and daily source of inspiration. It is the momentum that pushes us forward to help elevate the quality of life for both caregivers and those who need it most: critically and chronically ill patients. By providing essential medicines and technologies for infusion, transfusion, and medical nutrition, we are helping advance the future of healthcare, making it even more accessible, reliable, and in tune with current and future needs.

Our principles:

The Fresenius Principles form the basis of our company culture, with which we support our #FutureFresenius strategy. They describe what we stand for and how we operate, collaborate, approach challenges and make decisions as individual Fresenius employees and as a whole team.

Role & responsibilities

• Confirm that production is carried out by appropriately qualified, experienced, and trained personnel.
• Ensure GMP-compliant operations across all manufacturing activities.
• Verify that manufacturing operations are clearly defined, systematically reviewed, and proven capable of consistently producing products of the required quality.
• Ensure manufacturing processes are properly validated.
• Provide assurance that critical process parameters are identified, controlled, and any changes are validated.
• Implement change control, event handling, and CAPA/action management processes in accordance with global Quality Management (QM) documents, monitor and trend accordingly.
• Maintain accurate records for equipment usage, calibration, maintenance, and repair including dates and responsible personnel.
• Oversee manufacturing equipment qualification, validation, and calibration programs.
• Ensure proper storage and handling of materials and products covering receipt, quarantine, sampling, storage, labeling, dispensing, processing, and packaging according to written procedures.
• Execute yield checks and quantity reconciliations to confirm no discrepancies exceed acceptable limits.
• Conduct in-process and environmental controls as required, ensuring accurate recording.
• Contribute to investigations of product quality defects.
• Control reprocessing or reworking of materials to prevent unauthorized use.
• Prevent cross-contamination and mix-ups during manufacturing, packaging, and labeling operations.
• Implement and monitor progress toward EHS policy objectives.
• Create, manage, and update documentation related to the Environmental Health & Management System.
• Maintain surveillance of compliance with legal and organizational requirements.
• Report EEHS performance metrics to top management.
• Conduct regular reviews of occupational risks and environmental aspects.
• Provide training and awareness to employees to minimize accidents and environmental impact.
• Liaise with corporate and global EEHS representatives regarding relevant issues.
• Conduct audits of the Environmental, Energy, and Health & Safety Management System
• Ensure realistic commitment to the production plan based on machine utilization and manpower availability.
• Collaborate with the Site Head to escalate and resolve key events affecting production, quality, and safety.
• Review and propose capital expenditure (CAPEX) and operational expenditure (OPEX) budgets.
• Lead and drive continuous improvement projects by identifying suitable opportunities and overseeing their implementation.
• Provide ongoing coaching and support to team members to build capability and strengthen performance.
• Proactively mitigate potential conflicts between internal and external stakeholders.