Quality Oversight Lead – GMP & CAPA Champion

GSK plc; Zebulon (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

GSK plc in the United States seeks an Experienced Operational Quality leader to oversee a small team providing quality oversight across manufacturing. You will partner with manufacturing and supply chain to protect product quality and patient safety, driving improvements and inspections readiness.

The role emphasizes clear decision-making, coaching, and hands-on QA leadership with visibility and impact across the site’s GMP areas. Onsite work is required.

Qualifications

• Bachelor’s degree in science, pharmacy, engineering, or related discipline, or equivalent pharmaceutical industry experience.
• 6+ years of manufacturing experience in pharmaceutical, biologics, distribution, supplier quality, or quality operations.
• Experience with quality systems such as deviations, CAPA, change control, and document control.
• Experience with data trending, statistical analysis, and root cause analysis tools.
• Experience across multiple dosage forms, packaging or device assembly activities.
• Strong knowledge of Quality Management Systems (QMS) principles.
• Strong written and verbal communication for cross-functional collaboration.

Responsibilities

• Lead and coach the Operational Quality team to deliver oversight of the Quality Management System.
• Monitor quality performance using metrics and trends; elevate risk and collaborate on CAPAs.
• Oversee investigations of deviations, non-conformances and complaints; drive root cause analysis.
• Support product introductions, transfers, changes; prepare for audits and inspections; coach teams and partners on inspection readiness.
• Provide scheduling and guidance to the quality team for GMP areas; ensure schedule adherence.
• Detect potential quality issues through real-time observation and timely interventions.
• Perform spot-checks across GMP areas to ensure compliance with GDP and data integrity principles.
• Collaborate with cross-functional teams to resolve quality issues and implement corrective/preventive actions.
• Review GMP documentation and records to ensure ALCOA++ data integrity.
• Support site audits/inspections as SME for Quality Oversight.

Skills

Quality Oversight

Data Trending

Root Cause Analysis

Cross-functional Collaboration

GxP Awareness

Communication Skills

Problem Solving

Quality Metrics

Auditing Support

Lean Management

Education

Bachelor's degree in science, pharmacy, engineering, or related discipline

Job description

GSK plc in the United States seeks an Experienced Operational Quality leader to oversee a small team providing quality oversight across manufacturing. You will partner with manufacturing and supply chain to protect product quality and patient safety, driving improvements and inspections readiness.

The role emphasizes clear decision-making, coaching, and hands-on QA leadership with visibility and impact across the site’s GMP areas. Onsite work is required.