Senior Specialist, QA for Suppliers & Incoming Materials
Minimum Level of Education : BS, Ir, Pharmacist, PhD Degree in a relevant scientific, quality or technical discipline and relevant experience in (bio)pharmaceutical manufacturing and/or quality operations. Be able to understand and work with regulatory constraints. Understand main vaccines manufacturing processes.
- Area of Specialisation: Sciences (biology, chemistry, pharmacist …) or engineering degree or other technical related fields.
Minimum Level of Job-Related Experience required :
- 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.
- Ability to function efficiently 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 ability in project management experience.
- Experience and management of negotiations and ability to influence stakeholders to ensure implementation of appropriate regulatory requirements and quality standards.
- Experience in planning and executing pharmaceutical supplier audits to identify, manage, correct and reduce significant risks / non-compliances.
- Knowledge of technologies used in material supply base.
- Demonstrated ability to function effectively across multiple cultures and geographic boundaries.
- Knowledge of cGMP regulatory requirements and standards.
Ensure quality of suppliers, service providers and Incoming materials for the whole the GSK Vaccines network.
Manage the life-cycle activities and qualification of incoming materials - including investigations, CAPAs, supplier notifications and internal changes - in order to ensure a robust supply pipeline within GSK vaccines.
Manage suppliers' relationship to ensure GSK quality requirements and expectations (audits, Quality meetings, SPE process ...).
Understand and deploy regulatory constraints (GMP, ISO …), as well as internal procedures, related to management of incoming materials.
Ensure implementation of QASIM business initiatives and quality improvement plans that will support a robust supply pipeline.
- Understand and manage proactively quality aspect of suppliers and materials qualifications in partnerships with key stakeholders (procurement/TLCM/QC/Engineering). Manage proactively implementation of Quality Agreements and negotiation of GSK product specification requirements.
- Manage adequately all investigations (deviations and market complaints) in partnership with TLCT, QC, Belgium manufacturing facilities and suppliers to identify and follow up root causes and CAPA's, as well as clear product impact assessment. Be able to manage multi-site investigations.
- Manage adequately supplier change notifications (with GSK user sites) to ensure appropriate review and implementation. Manage all common and critical changes, and escalate issues if required.
- Escalate suppliers/quality issues to stakeholders through appropriated escalation processes. Manage actions of mitigation (QEF, BPDR, …) including global assessment for GSK Vx
- Perform and/or support supplier quality system audits and assess supplier capability to meet product requirement specifications. Manage proactively supplier quality risks and areas for improvement to ensure actions are incorporated into supplier corrective and preventive action plans. Manage supplier approval processes and suppliers corrective and preventive action plans to completion.
- Perform supplier performance measurement activities to improve compliance across the supply base. Act as key member to the Technical Lifecycle team meetings. Promote supplier Quality Improvement projects and contribute to Supplier Quality Monitoring.
- Manage proactively current regulatory requirements, as well as internal, environment related to incoming materials. Be aware to external regulatory environment and industry trends.
- "Promote a customer focus spirit. Cultivating a network of collaborative internal relationship and supplier network.
- Promote continuous improvements and customer focus spirit"
- Serve as a Site Liaison to provide an effective link between the site business needs
and the QASIM department to ensure full understanding of site requirements, priorities, issues and provide support to GSK sites during internal and regulatory inspections.
- Manage trainees and externals in their specific job.
- Serve as back-up of the team head to manage critical initiatives and critical issues and people
- Able to manage of small team of 2-3 persons (if appropriated)
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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