Global Quality Assurance and Regulatory Affairs Systems Manager
2 weeks ago
Overview
Werfen
At Werfen, we are a growing, family-owned, innovative company founded in Barcelona, Spain. As a worldwide leader in specialized diagnostics, we strive for excellence in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Our commitment to innovation and quality drives us to develop customized assays and biomaterials through our Original Equipment Manufacturing (OEM) business line.
We operate directly in 30 countries and in more than territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Job Summary
The Global QA/RA Systems Manager will provide leadership, planning, and project coordination to develop a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems. This role will facilitate efficient operations to meet current and future business needs by collaborating with QA/RA partners, IT, and outside vendors.
Responsibilities
- Develop a global strategy for the implementation, maintenance, operations, and optimization of the eQMS platforms.
- Leverage synergies between processes and workflows in the different Technology Centers and promote standardization/harmonization to the extent possible.
- Lead the Digital Board QARA meetings from the QA/RA side.
- Conduct and participate in the analysis of workflows and design of functionality and/or improvements to systems.
- Identify opportunities for process improvement, automation, application operational efficiency, and security.
- Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders needs.
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