Quality SAP & Process Improvement Specialist

GSK; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

GlaxoSmithKline, a global biopharma leader, seeks a Quality Unit Business Process Specialist to oversee SAP processes, rules and system interdependencies, ensuring cGMP compliance and data integrity across production.

You will partner with operations, engineering, IT and quality to translate business needs into documented processes, support continuous improvement and lead QA activities related to SAP master data, deviations and CAPA.

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or related field.
• 3–5 years’ experience in cGMP production or quality control.
• 1–3 years’ experience designing or implementing business processes or SAP.
• Experience with change control, CAPA, or deviation investigations.

Responsibilities

• Provide QA oversight for Production SAP use, data, and compliance.
• Act as site Quality Consultant for SAP; advise on master data.
• Lead design, documentation, and maintenance of quality unit processes and SOPs.
• Collaborate with cross-functional teams to translate requirements into controls.
• Monitor quality metrics and drive process improvements to reduce risk.

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 or related field

3–5 years’ experience in cGMP production or quality control

1–3 years’ experience designing or implementing SAP

Tools

SAP systems

Job description

GlaxoSmithKline, a global biopharma leader, seeks a Quality Unit Business Process Specialist to oversee SAP processes, rules and system interdependencies, ensuring cGMP compliance and data integrity across production.

You will partner with operations, engineering, IT and quality to translate business needs into documented processes, support continuous improvement and lead QA activities related to SAP master data, deviations and CAPA.