R&D Quality Operations Lead — GMP & Continuous Improvement

GSK; United States; Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

GSK in the United States is seeking a seasoned Quality professional to deliver operational quality activities that protect patient safety and ensure reliable supply across manufacturing and supplier partners. You will collaborate with manufacturing, regulatory, and external teams to simplify quality processes and drive continuous improvement.

This role offers meaningful impact, growth opportunities, and the chance to leadQuality R&D Operations activities, approve GMP documents, participate in

Qualifications

• Bachelor's degree required in scientific, engineering, pharmacy, or related discipline.
• Minimum 5 years of experience in Quality roles in a highly regulated environment (EMA/ FDA/ MHRA).
• Experience with cGMP and regulations applicable to GSK and quality systems; handling deviations, corrective and preventive actions.

Responsabilités

• Develop and incorporate effective processes and procedures in Quality R&D Operations; support site commissioning and qualification.
• Approve GMP documentation, SOPs, batch records, validation docs, and change controls; participate in investigations and CAPA follow-up.
• Participate in audits/assessments and support regulatory inspections; identify risks and communicate mitigation.
• Lead training and guidance to ensure compliance across customers, suppliers, and internal teams.
• Provide quality input for product introductions, transfers, and regulatory readiness; monitor metrics and drive improvements.

Connaissances

Quality Management

Regulatory Compliance

Audits & Investigations

Process Improvement

Cross-functional Collaboration

Formation

Bachelor's degree in scientific, engineering, pharmacy or related

Outils

GMP Documentation Systems

Description du poste

GSK in the United States is seeking a seasoned Quality professional to deliver operational quality activities that protect patient safety and ensure reliable supply across manufacturing and supplier partners. You will collaborate with manufacturing, regulatory, and external teams to simplify quality processes and drive continuous improvement.

This role offers meaningful impact, growth opportunities, and the chance to leadQuality R&D Operations activities, approve GMP documents, participate in