Quality Oversight Lead – GMP & CAPA Expert

Regulatory Jobs; Zebulon (NC); Presencial; USD 110 000 - 160 000; Tempo integral

Resumo da oferta

GSK in North Carolina is seeking a Quality Oversight Leader to head a small team ensuring GMP compliance across manufacturing and QA documentation. The role focuses on risk assessment, CAPA, investigations, and cross-functional collaboration to protect patient safety and product quality.

You will drive audits, CAPAs, and continuous improvement while maintaining ALCOA++ data integrity and GDP compliance. onsite, with strong emphasis on regulatory readiness and cross-functional engagement.

Qualificações

• Bachelor’s degree in science, pharmacy, engineering, 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.
• Proven experience and strong knowledge of the application of the principles of Quality Management Systems (QMS).
• Strong written and verbal communication skills for cross-functional collaboration and supplier engagement.

Responsabilidades

• Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System. Monitor quality performance using metrics and trends, escalate risk, and collaborate on corrective action plans.
• Oversee investigations of deviations, non-conformances and complaint-related issues and drive robust root cause analysis. Review and approve batch records, certificates and quality documentation to meet regulatory and good documentation standards.
• 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 quality oversight of all GMP areas ensuring all requirements have been met, and the defined schedule is followed.
• Maintain presence across areas of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations.
• Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects.
• Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards that include production, testing, QC, warehouse, facilities and utilities.
• Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.
• Review GMP documentation and records ensuring Good Documentation Practice (GDP) is being maintained following ALCOA++ principles for data integrity, audit and traceability.
• Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated and support timely implementation of remedial actions.
• Track and trend quality oversight observations on collected data and facilitate mitigation actions and regularly update and maintain the quality oversight risk assessment.
• Participates in and supports site-based audits/inspections as SME for Quality Oversight.

Conhecimentos

Quality Oversight

Data Trending

Root Cause Analysis

Cross-functional Collaboration

Quality Documentation

Formação académica

Bachelor’s degree in science/engineering/pharmacy

Ferramentas

QMS software

GDP tracking tools

Descrição da oferta de emprego

GSK in North Carolina is seeking a Quality Oversight Leader to head a small team ensuring GMP compliance across manufacturing and QA documentation. The role focuses on risk assessment, CAPA, investigations, and cross-functional collaboration to protect patient safety and product quality.

You will drive audits, CAPAs, and continuous improvement while maintaining ALCOA++ data integrity and GDP compliance. onsite, with strong emphasis on regulatory readiness and cross-functional engagement.