Supplier Quality Professional
United States, Greenwood (South Carolina)
United States, Portsmouth (New Hampshire)
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The role is managing processes and tools, operations and activities enabling Quality Supply Chain and Compliance at a global level. The responsible person executes global quality compliance and supply chain activities deriving from the implementation of global supply chain projects and compliance expectations from Health Authorities. The role supports the supply of materials and services to Lonza within area of responsibility by assessing the quality of the Suppliers and their ability to meet defined requirements utilizing tools such as Quality Risk Management (QRM), supplier assessment/audit, change management, and complaint/deviation trend management.
- Supplier Lifecycle management
- Support supplier lifecycle : Onboarding, Monitoring and decommissioning.
- Manage global Change control process regarding supplier management (internal and external suppliers), linked to materials management and supplier changes impacting Lonza globally.
- Responsible to manage QAA templates and to complete / revise QAA and SCL in due time, route for review before initiating approval process. Interact with the suppliers and the sites as needed to complete this activity.
- Support Reporting on QA Supplier performance for all assigned processes - this is to include Risk Assessment ranking and managing of defined KPI’s.
- Support global process such as materials management, Vendor Change Notifications (VCN), Supplier / Service Provider Assessment Request (SSPAR) and generation/processing of Supplier Quality Agreements.
- Support global activities related to GMP, Good distribution practices, warehousing.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
- Participates in review of revision updates to GSQ governing documentation
- Quality Compliance
- Maintain quality and compliance defined KPIs and provide reports to management as assigned.
- Systems and Tools
- Manage assigned systems and tools in an optimized way to facilitate lean global activities owned by QA Ops (such as audit management, global inspection readiness, supply chain and other quality management processes). Ensure that the systems and tools required for these processes are established and maintained to meet the business needs
- Ensure with peers and supervisor, that the assigned project is embedded into the overall concept for the QA Ops owned processes; ensure that process is aligned with systems used by other stakeholders (exchange of data / information, lean process, elimination of redundancies)
- Collaborate closely with management and peers to understand the needs and apply changes as applicable
- Provide content for the communication platform of the Global Quality Compliance and Supply Chain Group for assigned projects
- Other activities
- Provide coaching and mentorship to less experienced members of the team.
- Provides constructive feedback to peers, manager and team members to promote quality culture
- Demonstrate the Lonza Quality Behaviors
- Bachelor’s degree required
- Working knowledge in cGMPs and cGDP requirements, ISO standards and understanding of the regulatory process and requirements
- Knowledge in Quality Supply Chain operations
- Experience in Supplier Qualification and Supplier Monitoring
- Understanding of risk assessment and risk management fundamentals/tools
- Experience in project management and ability to multi-task.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.