Lonza
QualityEngineering,QAExpert,FrontEnd
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Engineering, QA Expert, Front End at Lonza. Lead Quality Integration. Oversee Qualification Programs”
What You'll Achieve.
Safeguards Lonza standards; De-risking large-scale investments; Ensure quality is integral; Mitigate compliance risks; Improve millions of lives
Industry & Context.
Mitigate compliance risks; Identify compliance risks
What They're Looking For.
Must Have
Quality compliance, GMP requirements, Technical guidance, Qualification programs, Alignment across engineering, Quality integral, Project initiation phases, Project design, Business case development, Qualification programs, Global investment projects, Regulatory expectations, GMP design reviews, Technical specifications, Facility layouts, Compliance standards, Industry best practices, Quality expectations, Capacity requirements, CAPEX pipeline stages, Technical recommendations, Quality oversight, Informed decision-making, Compliance risks, Data integrity, Lonza’s data integrity, Proactively identify gaps, Implement improvements, Front End activities, Lonza standards, International GMP regulations, Continuous Improvement, Evolving GQE objectives, Business objectives, Expectations, Quality capacity, Stakeholder expectations, Ideation, Strategic relevance, Quality perspective, Feasibility, Business case, Technical feasibility, Conceptasic Design, Approve CAPEX/OPEX, Design concepts, GMP regulations, FDA, EMA, Engineering, Design, Collaborative Influence, Senior management, Cross-functional teams, Globally, Analytical Rigor, Attention to detail, Technical documentation, Compliance risks
What You'll Do.
Lead Quality Integration
Oversee Qualification Programs
Execute Design Reviews
Drive Strategic Alignment
Provide Expert Guidance
Champion Data Integrity
Ensure Regulatory Adherence
Support Continuous Improvement
How You'll Work.
Team & Collaboration
Collaborate with Global Engineering; Collaborate with Senior Management; Work with cross-functional teams globally
Process & Methodology
Project ideation, Stage Gate 2, CAPEX investments, Project design, Business case development, Qualification programs, Global investment projects, Design reviews, Technical specifications, Facility layouts, CAPEX pipeline stages, Decision-making, Gate -1, Gate 0, Gate 1, Gate 2, Conceptasic Design
Full Job Description
## Job Description Summary 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 objecti
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