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

100055 Fresenius Kabi Deutschland GmbH; Bad Homburg vor der Höhe; Vor Ort; EUR 75.000 - 95.000; Vollzeit

Zusammenfassung

A leading healthcare company in Bad Homburg seeks a Process Architect (m/f/d) for Quality Management. You will excel in developing and optimizing quality processes, implementing cutting-edge platforms like SAP and integrating AI solutions. The ideal candidate will possess extensive experience in quality management with a focus on compliance. This full-time role offers an opportunity to make a significant impact in a collaborative environment.

Leistungen

International travel for training

Collaborative working environment

Qualifikationen

• Extensive experience in quality management processes.
• Proven track record in implementing quality management platforms.
• Experience integrating AI solutions in quality management.

Aufgaben

• Develop and optimize quality management processes.
• Support implementation of modern Quality Management Platforms.
• Ensure compliance with regulatory requirements.

Kenntnisse

Quality Complaint Management

Process Design

Artificial Intelligence Integration

Regulatory Compliance

Analytical Skills

Ausbildung

University degree in Life Sciences, Quality Management, Engineering

Tools

SAP QM

IQVIA

Veeva

Jobbeschreibung

Process Architect Quality Management / Complaint Management (m/f/d) page is loaded

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

Apply locations Bad Homburg (H28-30) time type Full time posted on Posted 30+ Days Ago job requisition id R-10007617

As a Process Architect (m/f/d), you will play a pivotal role in shaping and refining our global quality management processes, with a special emphasis on Quality Complaint Management and Quality Event Management. You will design and document comprehensive process templates tailored specifically for the dynamic Pharmaceutical and MedTech industries.

Embrace the opportunity to leverage cutting-edge quality management platforms such as SAP QM, IQVIA, Veeva, or others and integrate innovative Artificial Intelligence solutions to revolutionize process efficiency, predictive analytics, and decision-making. Your expertise will be crucial in driving digital transformation and ensuring that our quality processes are not just compliant but are at the forefront of industry standards.

Join a collaborative environment where you will work closely with IT and business stakeholders to ensure the seamless integration of new systems with existing infrastructures. Lead the global deployment and rollout of these processes across our manufacturing sites worldwide, contributing to operational excellence and regulatory compliance.

Your assignment

Process Design & Standardization

• Develop and optimize quality management processes, with a focus on Quality Complaint Management and Quality Event Management.

• Design and document global process templates tailored for Pharmaceutical and MedTech operations.

• Define critical process parameters and master data elements required for effective process execution.

Platform Implementation & Integration

• Support the implementation of modern Quality Management Platforms (e.g., SAP QM, IQVIA, Veeva, others).

• Integrate Artificial Intelligence solutions to enhance process efficiency, predictive analytics, and decision-making.

• Collaborate with IT and business stakeholders to ensure seamless integration of new systems with existing infrastructures.

Global Deployment & Collaboration

• Work closely with global manufacturing sites and the central business transformation team to deploy standardized quality processes.

• Collect and analyze feedback to drive continuous process improvement and refinement.

Regulatory Compliance & Quality Assurance:

• Ensure that all designed processes and implementations comply with relevant regulatory requirements and industry standards.

• Collaborate with quality assurance teams to develop testing protocols and conduct validations.

• Document process flows, requirements, and test results in accordance with GxP regulations.

Your profile

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

• Extensive experience in quality management process design, focusing on Quality Complaint Management and / or Quality Event Management.

• Proven track record in implementing modern quality management platforms (SAP QM, IQVIA, Veeva, etc.) in the pharmaceutical or MedTech industries.

• Experience integrating Artificial Intelligence solutions into quality management processes.

• Demonstrated expertise in defining master data and managing digital transformation initiatives.

• Strong understanding of quality management principles, regulatory requirements, and best practices in the pharmaceutical and MedTech sectors.

• Proficiency in using quality management software platforms and advanced data analytics tools.

• Experience in creating detailed process documentation, including process flows, requirements, and testing protocols.

• Excellent verbal and written communication skills, capable of conveying complex concepts to diverse audiences.

• Strong interpersonal skills with the ability to collaborate effectively with global teams and stakeholders.

• Exceptional analytical skills with a keen attention to detail.

• Proven ability to identify issues, troubleshoot challenges, and implement innovative solutions.

• Demonstrated project management expertise with experience leading cross-functional teams.

• Ability to manage multiple priorities and drive projects to successful completion in fast-paced environments.

• Proactive, adaptable, and self-motivated, with a strong commitment to continuous improvement.

• Willingness to travel internationally to support global implementations and training initiatives.

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( www.fresenius-kabi.com ) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients.

With more than 40,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life.