Quality SAP & Process Excellence Specialist

GSK; Marietta (PA); On-site; USD 90,000 - 140,000; Full time

Job summary

GSK is seeking a Quality Unit Business Process Specialist to oversee SAP processes and quality systems at a United States manufacturing site. You will partner with operations, engineering, IT and quality to design, implement and sustain quality processes, ensuring production remains compliant and reliable.

You will translate business needs into clear SOPs and support continuous improvement, with emphasis on change control, CAPA, deviations, and data integrity.

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 designing or implementing business processes or SAP systems.
• Experience with cGMP change control, procedures, and documentation.
• Strong communication skills and on-site collaboration with cross-functional teams.

Responsibilities

• Quality Assurance oversight of Production SAP use, business rules, and compliance.
• Serve as site Quality Consultant for SAP and advise on master data needs.
• QA oversight of QC Master Data per procedures and CFR requirements.
• Lead design, documentation, and maintenance of quality unit processes and SOPs.
• Train users on SAP business processes and support QA systems changes.

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

MES

LIMS

Job description

GSK is seeking a Quality Unit Business Process Specialist to oversee SAP processes and quality systems at a United States manufacturing site. You will partner with operations, engineering, IT and quality to design, implement and sustain quality processes, ensuring production remains compliant and reliable.

You will translate business needs into clear SOPs and support continuous improvement, with emphasis on change control, CAPA, deviations, and data integrity.