Quality Assurance (QA) Expert Front End

Role Overview

As a Quality Assurance (QA) Expert Front End, you will serve as a strategic quality partner in global engineering and capital investment projects. Your primary responsibility will be to ensure the integration of GMP compliance, regulatory expectations, and Lonza quality standards from the initial project phases through design and feasibility assessments. Your contribution will play a crucial role in mitigating risks associated with large-scale CAPEX investments by incorporating quality requirements into project design, engineering decisions, and early-stage governance processes.

Key Responsibilities

• Embed GMP and quality requirements during project initiation and design phases (SG-1 to SG-2)
• Ensure compliance is integrated into business case development and technical planning
• Provide QA oversight for global investment and infrastructure projects
• Support alignment between engineering design, operations requirements, and regulatory expectations
• Conduct detailed GMP design and documentation reviews
• Ensure facility layouts, systems, and technical specifications meet compliance standards
• Validate project feasibility from a quality perspective (SG-0)
• Confirm business case and compliance alignment (SG-1)
• Review and approve CAPEX/OPEX design concepts (SG-2)
• Partner with engineering, operations, and senior leadership teams globally
• Provide expert QA guidance to support decision-making and risk mitigation
• Ensure adherence to GMP standards (FDA, EMA, and other global regulations)
• Promote and enforce data integrity principles across all project documentation
• Identify gaps in quality processes and drive improvements in early project governance
• Support ongoing enhancements within Global Quality Engineering (GQE) frameworks

Qualifications Required

• Bachelors or Masters degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or related field
• Strong experience in GMP-regulated environments (pharma, biotech, life sciences)
• Background in Quality Assurance within engineering, manufacturing, or CAPEX projects
• Experience with GMP standards (FDA, EMA, ICH guidelines)
• Understanding of facility design, qualification processes, or capital project lifecycle
• Strong documentation review and compliance assessment skills

Role Impact

Your role as a Quality Assurance (QA) Expert Front End is pivotal in ensuring that quality is an integral aspect of global engineering and investment projects. By early integration of GMP compliance into the design phase, you directly contribute to the development of safer, more efficient, and regulatory-compliant manufacturing facilities that will support the production of future medicines. Role Overview

As a Quality Assurance (QA) Expert Front End, you will serve as a strategic quality partner in global engineering and capital investment projects. Your primary responsibility will be to ensure the integration of GMP compliance, regulatory expectations, and Lonza quality standards from the initial project phases through design and feasibility assessments. Your contribution will play a crucial role in mitigating risks associated with large-scale CAPEX investments by incorporating quality requirements into project design, engineering decisions, and early-stage governance processes.

Key Responsibilities

• Embed GMP and quality requirements during project initiation and design phases (SG-1 to SG-2)
• Ensure compliance is integrated into business case development and technical planning
• Provide QA oversight for global investment and infrastructure projects
• Support alignment between engineering design, operations requirements, and regulatory expectations
• Conduct detailed GMP design and documentation reviews
• Ensure facility layouts, systems, and technical specifications meet compliance standards
• Validate project feasibility from a quality perspective (SG-0)
• Confirm business case and compliance alignment (SG-1)
• Review and approve CAPEX/OPEX design concepts (SG-2)
• Partner with engineering, operations, and senior leadership teams globally
• Provide expert QA guidance to support decision-making and risk mitigation
• Ensure adherence to GMP standards (FDA, EMA, and other global regulations)
• Promote and enforce data integrity principles across all project documentation
• Identify gaps in quality processes and drive improvements in early project governance
• Support ongoing enhancements within Global Quality Engineering (GQE) frameworks

Qualifications Required

• Bachelors or Masters degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or related field
• Strong experience in GMP-regulated environments (pharma, biotech, life sciences)
• Background in Quality Assurance within engineering, manufacturing, or CAPEX projects
• Experience with GMP standards (FDA, EMA, ICH guidelines)
• Understanding of facility design, qualification processes, or capital project lifecycle
• Strong documentation revie