Specialist, QA Supplier & Incoming Material
Effective Incoming Material Quality Management has been identified as being critical to the success of GSK Vaccines. The purpose of this role to create and maintain business processes and systems to complement business initiatives currently being or planned to be implemented within GSK Vaccines. Ensure operational support and assistance to the QS&IM product and compliance teams.
• Drive and improve the quality agreement process and templates in alignment with QMS and regulatory expectations. Provide operational support to QS&IM product teams. Lead the Quality Agreement QA network.
• Drive the supplier change notifications (SN) process for QS&IM in alignment with QMS, regulatory expectations and GSK policies. Provide support to the QS&IM product teams by ensuring the administration, record, tracking and follow up of all suppliers SN's managed by QS&IM.
• Ensure definition and follow up of L1 audit Universe/Planning within Quality Share Services in accordance with GSK policies. Execute L1 audits within QS&IM.
• Ensure coordination of the supplier performance evaluation process with procurement department in alignment with QMS and regulatory expectations. Ensure coordination and planning with procurement. Provide operational support to QS&IM team's by preparing BE's data and collecting GSK's Vaccine results.
• Ensure coordination and deployment of Quality Share Services Data Integrity program.
• QS&IM Single Point of Contact for GSK Quality alerts. Perform first assessments and coordinate final QS&IM response with IM team's and management. Ensure adequate and regular reporting to stakeholders.
• Develop and manage strong partnership with GMS and International QS IM vaccine's organizations based on regular quality meetings to realize operational/process alignment and to ensure QS&IM positions are declined into QMS.
• Ensure the review of "Product Quality Review" related to incoming material.
• Responsible to define and maintain the training matrixes within the QS&IM. Be the QS&IM representative for training topics and improvements.
• Ensure definition, maintenance and formalization of key contact lists within QS&IM. Ensure adequate communication to stakeholders.
• Participate to continuous improvements programs related to the management of suppliers, incoming materials, processes or internal projects to improve QS&IM performance.
• Ensure timely escalation of critical events to appropriate governance body (leadership tem, Risk management Compliance Committee, TIER meetings, ...).
• Support QS&IM and GSK Vaccine sites undergoing corporate (L3) and regulatory inspections (L4) for all processes related to her activities.
• University degree (area of specialization: IT Systems and technologies)
• Science degree and experience in pharmaceutical manufacturing and quality operations.
• Experience in negotiation and influencing improvement activity (especially in quality culture and GMP compliance) to ensure implementation of appropriate corrective/preventive actions, quality standards and quality agreements.
• Knowledge of regulatory and quality system requirements and ability to explain, influence and negotiate with supplier organizations to comply with standards.
• Good verbal and written communications skills to ensure issues, risks and opportunities are well understood by all parties and that effective actions are put in place.
• Demonstrated ability to function effectively in a matrix organization in order to ensure effective use of resource and communication of issues to all impacted sites/functions.
• Experience with Microsoft office applications and have the ability to learn new software applications such as SAP.
• Demonstrated experience in audit techniques, including listening and interviewing skills.
• Demonstrated ability to function effectively in a matrix organization.
• Demonstrated ability to function effectively across multiple cultures and geographic boundaries.
• Good knowledge of the pharmaceutical industry.
• The role requires up to 10% travel.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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