Krzysztof Szajek

This position is responsible for leading the relationship with each External Supplier in Region from a Quality perspective to ensure GSK’s product quality and reputation is protected. Additionally this role is accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned external supplier(s). These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production, Site Management and others.
• Lead Quality Agreement negotiations with External Suppliers and implement Quality Systems performance management with appropriate KPIs for contractual parameters. Ensure regulatory compliance is managed through flow of regulatory information to the releasing Sites as governed by Quality Agreements.
• Monitor the quality performance of the External Supplier driving remedial action where necessary. Examine external suppliers’ key performance indicators, such as complaints and BnRFT as mechanism to propose continuous improvement initiatives. Apply appropriate Risk management tools with each External Supplier, escalating significant risks for resolution.
• Partner with External Suppliers to assure that potential quality issues are identified, communicated and promptly resolved in order to assure a secure source of supply of quality product.
• Liaise with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality.
• Drive periodic review of Quality Systems at the External Suppliers, to complement audit processes. Conduct root cause analysis reviews for identification of issues and development of remedial actions.
• Evaluate effectiveness of the external suppliers Quality Unit and systems and influence External Suppliers promoting robust systems under self-sufficient organizations. Report all serious cGMP/Regulatory compliance issues.
• Review and respond to External Supplier regulatory inspections on matters that involve activities related to GSK products. Assess impact of inspection and External Supplier responses to Regulatory observations prior to submission to associated agency.
• Work with external suppliers to establish meaningful CAPAs, in response to GSK audit observations and manage to acceptable closure.
• Provide or support technical assessment and authorization for new product introductions, review and approve significant documentation associated with the introduction of a new product at External Suppliers. Provide quality requirements for technical transfer projects, validation exercises, laboratory methods, stability protocols, SOPs, internals specifications, master batch records and others as needed.