Quality Unit Business Process Specialist

About the role

GSK is hiring a Quality Unit Business Process Specialist to support a United States manufacturing site. The role sits within the Quality Assurance Operations and is co-responsible for site and department results. It focuses on quality oversight of SAP processes, business rules and systems, working with operations, engineering, IT and quality teams to design, implement and sustain compliant, reliable processes.

Key responsibilities

• Oversee production SAP use, business rules, outcomes and compliance, including creation of new material master data
• Oversee serialization line client recipe creation and modification
• Act as key contact for internal departments and other sites on master data, and as site Quality Consultant for SAP issues
• Provide input to global procedural revisions so site master data needs are met
• Oversee QC master data against procedures, policies, standards and FDA regulations
• Be subject matter expert for local SOPs using SAP and QA approver for QC SOPs on QC master data
• Ensure no conflict between site processes, compliance with CFR requirements and GSK higher-level documents, and consistent, clear use of SAP across departments
• Train users on SAP business processes and assist with QA systems objects (deviations, change controls, CAPA)
• Lead design, documentation and maintenance of quality unit business processes and SOPs, and support change control, risk assessments and quality impact evaluations
• Contribute to investigations, root cause analysis and CAPAs, and monitor quality metrics and trends

Required profile

• Bachelor's degree in life sciences, engineering, quality or a related technical field
• 3-5 years' experience in cGMP production or quality control for cGMP manufacturing
• 1-3 years' experience designing or implementing business processes or SAP systems
• Experience performing implementation and changes under cGMP change control
• Practical experience writing or maintaining procedures, work instructions and process documentation
• On-site presence at a US manufacturing location; hybrid or remote work is not available

Required skills

• Expert knowledge of cGMP quality systems and intermediate knowledge of SAP or business processes
• Good Manufacturing Practices and Good Documentation Practices
• Change control, CAPA and deviation investigation experience
• Strong verbal and written communication and ability to work with cross-functional teams
• Preferred: biologics or pharma experience with computerized systems (MES, LIMS), risk assessment tools, DMAIC-style root cause analysis, quality KPI monitoring, and coaching experience