Quality Unit Lead, Drug Substance Ops

GlaxoSmithKline; Marietta (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

GlaxoSmithKline is seeking a Quality Unit Business Process Specialist to support drug substance operations at a U.S. site. You will partner with manufacturing, quality, IT, and engineering to ensure compliant, efficient quality processes and master data management.

The role emphasizes quality systems oversight, process improvement, and coaching teams to uphold high standards, with clear impact on product quality and regulatory readiness.

Qualifications

• Bachelor's degree in life sciences, engineering, quality, or related technical field.
• Minimum 3 years' experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment.
• Experience designing, implementing, or supporting quality business processes, preferably involving SAP or similar ERP.

Responsibilities

• Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards. Act as a key quality contact for cross-functional teams and sites on master data, process changes, and procedural questions. Develop, review, and maintain quality unit business process documentation and SOPs.

Skills

Quality oversight

GxP Regulations

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in life sciences or related field

Tools

SAP

LIMS

MES

Job description

GlaxoSmithKline is seeking a Quality Unit Business Process Specialist to support drug substance operations at a U.S. site. You will partner with manufacturing, quality, IT, and engineering to ensure compliant, efficient quality processes and master data management.

The role emphasizes quality systems oversight, process improvement, and coaching teams to uphold high standards, with clear impact on product quality and regulatory readiness.