Role Overview
SoTalent is hiring a mid-level Quality Assurance (QA) Expert Front End. This is a full-time role in IN. Part of SoTalent's Risk hiring. Full responsibilities, required qualifications, and the apply link are listed in the description below.
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Job Description
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
Frequently Asked Questions
How do I apply for the Quality Assurance (QA) Expert Front End position at SoTalent?
Use the Apply button above to submit your application directly to SoTalent. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.
Where is the Quality Assurance (QA) Expert Front End position at SoTalent located?
This position is based in IN. SoTalent has not indicated remote or hybrid options for this role, so candidates should plan for on-site work.
What does a Quality Assurance (QA) Expert Front End at SoTalent earn?
SoTalent has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.
When was the Quality Assurance (QA) Expert Front End role at SoTalent posted?
This role was posted on April 23, 2026 (52 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.
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