Quality Engineering, QA Expert, Commissioning & Qualification Audit and Inspection Support

The QA Expert, Front End serves as a strategic quality partner within the Global Quality Engineering (GQE) team. This role ensures that global growth projects and CAPEX investments are designed with quality compliance embedded from the outset. By providing oversight from project ideation through Stage Gate 2, the position safeguards Lonza standards and international GMP requirements, de‑risking large-scale investments before execution. The QA Expert delivers technical guidance, supports qualification programs, and drives alignment across engineering and senior management to ensure quality is integral to all early-stage project decisions.

Key Accountabilities

• Lead Quality Integration: Manage quality and compliance responsibilities during project initiation phases (SG‑1 to SG‑2), embedding requirements into project design and business case development.
• Oversee Qualification Programs: Support strategic set‑up of qualification programs for global investment projects, aligning platform, operations, and customer needs with regulatory expectations.
• Execute Design Reviews: Conduct GMP design reviews to ensure technical specifications and facility layouts meet compliance standards and industry best practices.
• Drive Strategic Alignment: Collaborate with Global Engineering and Senior Management to align quality expectations and capacity requirements during early CAPEX pipeline stages.
• Provide Expert Guidance: Deliver technical recommendations and quality oversight to facilitate informed decision‑making and mitigate compliance risks.
• Champion Data Integrity: Uphold Lonza's data integrity principles; proactively identify gaps and implement improvements.
• Ensure Regulatory Adherence: Validate that all Front End activities comply with Lonza standards and international GMP regulations.
• Support Continuous Improvement: Perform additional duties as required to support evolving GQE and business objectives.

Project Scope & Stage Gate Responsibility

The QA Expert provides oversight across the following milestones:

PhaseMilestonePrimary Responsibility

Gate -1ExpectationsAlign quality capacity and stakeholder expectations

Stage Gate 0IdeationValidate strategic relevance of the project from a quality perspective

Stage Gate 1FeasibilityConfirm business case and technical feasibility

Stage Gate 2Concept/Basic Design Approve CAPEX/OPEX (CAR) and design concepts

Core Competencies

• Quality Mindset: Deep understanding of GMP regulations (FDA, EMA, etc.) and their application in engineering and design.
• Collaborative Influence: Ability to work effectively with senior management and cross‑functional teams globally.
• Analytical Rigor: Strong attention to detail in reviewing technical documentation and identifying compliance risks.

About Lonza

At Lonza, our people are our greatest strength. With more than 30 sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values—Collaboration, Accountability, Excellence, Passion, and Integrity—reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. Lonza is committed to creating an inclusive environment for all employees.