Compliance Specialist

1. Global Quality Supply Chain

• Participate in or lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives e.g. Quality/Compliance Task Forces, remediation projects
• Communicate identified deficiencies and compliance risks to appropriate management, business, operations and quality heads as applicable
• Actively manage assigned global quality activities emanating from Supply Chain initiatives and projects such as materials management
• As a global representative, manage assigned activities related to Good distribution practices, warehousing.
• As assigned responsible that sites implement and sustain activities related to Vendor Supply Chain Integrity process.
• As assigned responsible to define and implement the process for Global Supplier Complaints in accordance with principles outlined in “Systems and Tools”

1.1 Supplier Lifecycle management

• Actively manage supplier lifecycle : Onboarding, Monitoring and decommissioning.
• Responsible to actively interface with major Supplier for which a business partnership has been assigned
• Manage global Change control process regarding supplier management (internal and external suppliers), linked to materials management and supplier changes impacting globally.
• As part of the supplier management, responsible that QAA templates are meeting Health Authority requirements and that QAA are completed, reviewed, approved and revised in due time
• Responsible for the Reporting on QA Supplier performance for all assigned processes - this is to include Risk Assessment ranking and managing of defined KPI’s.

1.2 Quality Compliance and quality risk management operations

• Create, distribute and track regulatory/compliance gap Analysis observations at the sites. Collaboration with Quality compliance teams is essential to ensure Gap Analysis observations and content is fostering increased compliance
• Responsible for the Regulatory intelligence process and tool (Redica) as assigned. The role ensures that information is used to its maximum potential: support to site inspection, gap assessment, trending of major Inspection observations…
• Responsible to manage global Quality Risk Management by coordinating frequent review of the site risk profile in regards to Quality Risks (CORP-28) as assigned. Analyse the data to define top quality and compliance risks at Lonza that is communicated to management.
• Responsible that metrics are set and maintained globally to measure quality compliance and provide KPIs to BU Quality councils and Global Quality Council

1.3 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
• For assigned projects, develop and maintain process in strong alignment with key stakeholder, define project scope, own the relevant URS and test scripts as required, lead project for development of system/process, its testing, implementation and release to users; responsible to provide required procedures, user manuals and training; if required ensure that local procedures are in place to successfully allow implementation at the site(s).
• 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