Quality Unit Process & Compliance Specialist

GlaxoSmithKline; United States; Teletrabalho; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

GSK in the United States seeks a Quality Unit Business Process Specialist to collaborate with manufacturing, quality, IT, and engineering teams, ensuring quality processes run smoothly and compliantly on-site at a US location.

You will oversee quality systems, drive improvements, and coach colleagues to maintain high standards, contributing to the company’s mission to unite science, technology and talent to get ahead of disease together.

Qualificações

• Bachelor's degree in life sciences, engineering, quality, or related technical field.
• Minimum 3 years' experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment.
• Experience designing, implementing, or supporting quality business processes, preferably involving SAP or ERP.

Responsabilidades

• Provide quality oversight for drug substance-related processes and systems, ensuring compliance with regulations and internal standards. Act as a key quality contact for cross-functional teams and sites on master data, process changes, and procedural questions. Develop, review, and maintain quality unit business process documentation and SOPs.
• Support investigations, root cause analysis, and corrective and preventive actions related to quality deviations and process issues.
• Facilitate quality impact assessments and risk reviews for process and system changes. Train and coach site colleagues on quality processes, documentation practices, and compliance requirements.

Conhecimentos

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Formação académica

Bachelor's degree in life sciences, engineering, quality, or related technical field

Ferramentas

SAP or ERP

Descrição da oferta de emprego

GSK in the United States seeks a Quality Unit Business Process Specialist to collaborate with manufacturing, quality, IT, and engineering teams, ensuring quality processes run smoothly and compliantly on-site at a US location.

You will oversee quality systems, drive improvements, and coach colleagues to maintain high standards, contributing to the company’s mission to unite science, technology and talent to get ahead of disease together.