Process Architect Quality & Complaint Management (m/f/d)

As a Process Architect Quality & Complaint Management, you will shape and continuously improve global quality management processes with a strong focus on Quality Complaint Management and Quality Event Management across Pharmaceutical and MedTech environments. You will drive digital transformation by designing standardized, compliant processes and leveraging modern quality platforms and AI-enabled solutions to enhance efficiency, transparency, and decision-making on a global scale.

Your responsibilities:

• Design, standardize, and continuously optimize global quality management processes, with a strong focus on Quality Complaint Management and Quality Event Management.

• Develop and maintain end-to-end global process templates, including process flows, roles, responsibilities, KPIs, and documentation aligned with Pharma and MedTech requirements.

• Define and govern critical process parameters, master data, and data models required for high-quality, compliant process execution.

• Support the implementation and configuration of modern Quality Management platforms (e.g., SAP QM, IQVIA, Veeva, or similar systems).

• Identify and integrate Artificial Intelligence solutions to improve process efficiency, automation, predictive analytics, and decision-making.

• Collaborate closely with IT, Quality, Manufacturing, and Business stakeholders to ensure seamless system integration with existing infrastructures.

• Lead and support global rollout and deployment of standardized quality processes across manufacturing sites worldwide.

• Collect, analyze, and incorporate user feedback and performance metrics to drive continuous improvement initiatives.

• Ensure all processes, systems, and documentation comply with GxP regulations, global regulatory requirements, and industry best practices.

• Partner with Quality Assurance to support validation activities, including requirements definition, testing protocols, execution, and compliant documentation.

Your qualifications:

• University degree in Life Sciences, Quality Management, Engineering, or a related discipline

• Extensive hands-on experience in quality management process design, with a strong focus on Quality Complaint Management and / or Quality Event Management in pharmaceutical or MedTech environments

• Proven track record in implementing modern quality management platforms (e.g. SAP QM, IQVIA, Veeva or comparable systems), including rollout, and user adoption

• Demonstrated experience in digital transformation initiatives, including master data definition and governance, end‑to‑end process documentation (process flows, requirements, testing protocols), and validation‑relevant deliverables.

• Practical experience integrating Artificial Intelligence and advanced analytics solutions into quality management processes to improve efficiency, automation, predictive insights, and decision-making.

• Strong knowledge of quality management principles, GxP regulations, validation requirements, and industry best practices within the pharmaceutical and MedTech sectors.

• Excellent analytical, problem-solving, communication, and stakeholder management skills, with the ability to translate complex concepts for diverse, global audiences and collaborate effectively across functions.

• Proven project management capabilities, including leading cross-functional teams, managing multiple priorities in fast‑paced environments, driving initiatives to completion, a proactive and improvement‑driven mindset, and willingness to travel internationally.

Drive the future of Quality — join #futurefresenius and apply now through our online portal to make an impact!