(Senior) Director Quality Efficiency & Optimization

Key Responsibilities:

• Lead continuous improvement initiatives, driving cultural and operational changes to integrate quality system, product, and process improvements into everyday business.
• Identify and enhance areas within the MSCQ network to ensure compliance while maximizing flexibility and efficiency.
• Harmonize MSCQ practices across sites (e.g., Validation, Process Control, and Test Methods).
• Develop and implement robust, sustainable, and efficient processes, methods, and procedures.
• Collaborate with process owners and stakeholders to implement lasting improvements.
• Provide quality leadership and hands-on support to FMCNA sites facing acute issues (e.g., product quality problems, process capability issues, FDA inspections).

Key Deliverables:

• Implement efficiency improvements within QOEHP
• Monitor and report QOEHP progress (including Master Project List and dashboard) to senior management
• Lead the QOEHP Core Team to identify and drive efficiency opportunities, collaborating with Manufacturing Quality, Supplier Quality, and Supply Chain Quality
• Manage the overall QOEHP program
• Establish a network of Subject Matter Experts (SMEs) in technical areas (e.g., inspection and test)

Required Experience:

• At least 10 years of experience in Quality Assurance, Quality Engineering, and/or Quality Systems, preferably in the Medical/Pharma industry
• Minimum of 3 years in a senior management or leadership role
• Proven experience in implementing global processes/standards
• Advanced project management experience
• Hands-on experience in a GMP/GDP environment
• Strong collaborative skills with excellent interpersonal and communication abilities, along with political awareness
• Ability to manage complex programs involving external organizations, partnerships, and diverse stakeholder groups
• Familiarity with FDA, MDD/MDR, and key international regulations for both devices and drugs
• Experience in talent development within a global engineering/scientific organization.
• Fluency in English; additional languages are a plus

Our offer to you

There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

• The opportunity to work on a mobile basis
• Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
• A large number of committed people with a wide range of skills, talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium-sized company