Quality Oversight Lead — GMP & CAPA Excellence

GlaxoSmithKline; Zebulon (NC); On-site; USD 100,000 - 140,000; Full time

Job summary

GlaxoSmithKline seeks a qualified quality professional to lead a small Operational Quality team responsible for quality oversight across manufacturing. You will partner with manufacturing and supply chain to safeguard patient safety and product quality, while coaching teams to improve processes and drive CAPAs.

The role emphasizes decision-making, regulatory readiness, and data-driven improvements across GMP areas, with on-site work in North Carolina, Zebulon area.

Qualifications

• Bachelor's degree in science, pharmacy, engineering, or related discipline or equivalent experience.
• 6+ years of manufacturing experience in pharma, biologics, distribution, supplier quality, or quality ops.
• Experience with quality systems: deviations, CAPA, change control, document control.
• Experience with data trending, statistical analysis, and root cause analysis tools.
• Experience across multiple dosage forms, packaging or device assembly.
• Strong knowledge of Quality Management Systems (QMS) and data integrity practices.

Responsibilities

• Lead and coach the Operational Quality team to oversee the Quality Management System and monitor quality performance.
• Investigate deviations, non-conformances and complaints; drive root cause analysis and approve docs (batch records, certificates).
• Support product introductions, transfers, changes; prepare for audits and inspections; coach teams on inspection readiness.
• Provide oversight and scheduling for quality activities to ensure GMP requirements are met and on schedule.
• Be the first line of contact for quality issues; participate in initial impact assessments for deviations.

Skills

Quality systems

Data analysis

QMS knowledge

Cross-functional collaboration

Documentation

Root cause analysis

Quality Assurance

Education

Bachelor's degree in science/pharmacy/engineering

Tools

CAPA system

Document control systems

Job description

GlaxoSmithKline seeks a qualified quality professional to lead a small Operational Quality team responsible for quality oversight across manufacturing. You will partner with manufacturing and supply chain to safeguard patient safety and product quality, while coaching teams to improve processes and drive CAPAs.

The role emphasizes decision-making, regulatory readiness, and data-driven improvements across GMP areas, with on-site work in North Carolina, Zebulon area.