oprandi & partner Basel – Basel

Our client is a global acting and one of the world’s leading research-focused healthcare groups. The Swiss production site is a cornerstone of our client’s global production and logistics network and employs some 1400 people. Comprising a state of the art centre of excellence for sterile production and the largest and most innovative packaging facility worldwide, the site serves around 130 markets every year. It also offers a host of interesting job opportunities.

 

Head Quality Assurance Unit (External Quality)

Through rigorous supplier quality management and risk-based oversight of external drug substance and drug product partners, the External Quality team supplements the manufacturing network in order to support our client’s ability to supply high quality product and meet the needs of our patients. In conjunction with the Regional Head of Supplier Quality Management (SQM), the Supplier Quality Manager Regional Platform Managers and the Supplier Collaboration Managers the Head of Quality Assurance Unit will develop and deploy the following throughout the supply chain for ‘direct materials’ (critical raw and starting materials, purchased Active Pharmaceutical Ingredients, excipients, packaging, medical devices, disposables. Implement SQM strategy, processes and systems, develop metrics and KPIs for the regional platform, develop and manage quality system review metrics and drive Continuous Improvement objectives.

Your responsibility | You lead, deploy and manage the SQM compliance program for the region to include Supplier Risk assessments, for-cause-audits, and performance monitoring reviews. You monitor supplier performance and investigate supplier quality issues, identify CAPAs and Perform supplier audits and ensure audits are performed to schedule. You perform complaint investigations related to Suppliers Lead process improvement projects Responsible for managing, negotiating and completing Quality agreements with suppliers Participate in Global Supplier Quality Management leadership activities. You implement at technology platform level the collaboration program for direct material suppliers and establish a communication plan across the technology platforms for all regions Supplier Quality. You troubleshoot and provide resolution of material and Supplier Quality issues by fostering effective inter-site, inter-departmental and cross-functional partnerships. You provide solutions to complex manufacturing, quality and negotiation.

 

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