Onsite Operational Quality Lead

GSK; Zebulon (NC); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

GSK is seeking an Operational Quality Leader in North Carolina to oversee a small quality team ensuring GMP compliance and robust product quality. You will collaborate with manufacturing and supply chain to maintain data integrity and drive corrective actions across multiple dosage forms.

The role emphasizes decision-making, coaching, and continuous improvement, with onsite requirements and a focus on patient safety and product quality.

Formación

• Bachelor’s degree in science, pharmacy, engineering, or a related discipline, or equivalent pharmaceutical industry experience.
• 6+ years of manufacturing experience from pharmaceutical industry, biologics manufacturing, 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 skills for cross-functional collaboration.

Responsabilidades

• Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System, monitor quality performance, elevate risk, and collaborate on CAPAs.
• Oversee investigations of deviations, non-conformances and complaint-related issues, drive robust root cause analysis, review batch records and quality documentation.
• Support product introductions, transfers and changes, prepare for and support audits and inspections, and coach internal teams and external partners on inspection readiness.
• Provide oversight, support, and accurate scheduling of activities to the quality team responsible for GMP areas, ensuring required standards and schedules are met.
• Maintain presence across areas and be the first line of contact to support initial management of quality issues and key decision-making across deviations’ initial impact assessment.
• Provide guidance during GMP activities to proactively detect potential quality issues and enable timely interventions to prevent deviations and defects.

Conocimientos

Data Integrity

Quality Assurance

Regulatory Compliance

Problem Solving

Technical Writing

GxP Regulations

Lean Management

Risk Awareness

Educación

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

Descripción del empleo

GSK is seeking an Operational Quality Leader in North Carolina to oversee a small quality team ensuring GMP compliance and robust product quality. You will collaborate with manufacturing and supply chain to maintain data integrity and drive corrective actions across multiple dosage forms.

The role emphasizes decision-making, coaching, and continuous improvement, with onsite requirements and a focus on patient safety and product quality.