Quality Unit SAP & Process Excellence Lead

GSK; Marietta (MS); On-site; USD 90,000 - 120,000; Full time

Job summary

GSK is seeking a Quality Unit Business Process Specialist to oversee SAP-based quality processes at a US manufacturing site. You will collaborate with operations, IT, engineering and quality to design, implement and sustain compliant quality workflows and master data management, ensuring traceability and CFR alignment.

You will lead process documentation, support change controls and CAPA activities, and train users across functions while driving continuous improvement in quality and production

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or a related technical field.
• 3-5 years’ experience in cGMP production or quality control for cGMP manufacturing; 1-3 years in business processes or SAP.

Responsibilities

• Act as the Quality Assurance oversight to Production SAP use, business rules, outcomes and compliance including creation of new material master data.
• QA Oversight for Serialization Line client recipe creation and modification.
• Serve as site Quality Consultant for SAP; provide input to global procedural revisions to address site Master Data needs.
• Oversee QC Master Data ensuring adherence to procedures, policies, standards and FDA regulations.
• Ensure familiarity with cGMPs, EHS procedures and facility regulatory guidelines.
• Be SME for local SOPs where SAP is used and QA approver for QC SOPs relating to QC master data.
• Train users related to SAP business processes.
• Assist with QA Systems objects (deviations, change controls, CAPA) involving SAP.
• Lead design, documentation and maintenance of quality unit processes and SOPs.
• Collaborate with cross‑functional teams to translate requirements into process controls.
• Support change control, risk assessments and quality impact evaluations.
• Contribute to investigations and CAPA to prevent recurrence.
• Monitor quality metrics and trends to drive improvements.

Skills

Data Integrity

Detail‑Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Bachelor’s degree in life sciences, engineering, quality, or a related technical field

Tools

SAP

LIMS

MES

Job description

GSK is seeking a Quality Unit Business Process Specialist to oversee SAP-based quality processes at a US manufacturing site. You will collaborate with operations, IT, engineering and quality to design, implement and sustain compliant quality workflows and master data management, ensuring traceability and CFR alignment.

You will lead process documentation, support change controls and CAPA activities, and train users across functions while driving continuous improvement in quality and production