Currently we are looking for a Senior. Auditor, Global Supplier Quality.
Lead supplier quality audits to ensure uninterrupted supply. Find solutions to mitigate adverse quality trends and drive continuous supplier and supply chain improvement.
Lead Supplier Quality audits at Lonza Suppliers to annual plan and follow up on agreed upon CAPAs. Assure issues are timely classified, communicated to the supplier and to Lonza Sites.
Responsible for finding solutions to mitigate adverse material or service quality trends and to drive continuous improvement for processes and product quality performance for assigned suppliers. Promptly notify and escalate to Regional Head Supplier Quality any potential quality or regulatory issues that may affect product quality or regulatory compliance.
Support Regional Head to ensure that Change requests are managed according to the Quality Agreement and Lonza SOPs from receipt, through to their implementation and closure.
Support Regional Head to develop and use quality risk management tools: such as quality agreements, complaint management and computerized systems in support of the supply chain.
Support improvements within Lonza Quality Management System for Global Supplier Quality and with Global Strategic Sourcing.
4-year University degree; preferred area of study: Life Sciences
At least 8 years’ experience in a regulated industry preferably pharmaceutical or biopharmaceutical with at least 4 years’ experience auditing (internal / external) manufacturing facilities, equipment, laboratories and service providers, supplier management
Strong knowledge of cGMPs, ISO standards and international regulations.
Knowledge of manufacturing processes and OE tools (i.e. statistical methods, FMEA, Six Sigma, Lean)
Ability to interpret and relate Quality standards to make sound quality decisions
Project management experience and ability to work on complex projects and with cross functional team members
Skilled to create executive summaries to proactively communicate any risk identified during assessment, ensuring proper escalation to the business
Good interpersonal, negotiation and communication skills
Fluent English required