\\n Global Supply Chain Quality Manager \\xe2\\x80\\x93 Based in Western Switzerland

• Support the development, execution, and delivery of global supply chain quality strategies for the company. Partner with Quality Site Heads, Global Quality Functions, R&D, Supply Chain, Operations & Marketing to assure Global Supply Chain Objectives are identified and fulfilled.
• Drive continuous improvement in the overall compliance profile for the company in Supply Chain. Continually evaluate systems and activities for Compliance to Quality Standards and Regulations.
• Identify where corrections or improvements are indicated. Provide support to other departmental activities as directed. Provide Subject Matter Expertise in evaluation and implementation of domestic and international regulatory GDP requirements.
• Establish and Maintain Quality System for Product Distribution including Company Affiliates and Distribution Partners. Creation and maintenance of applicable policies and procedures.
• Collaborate to ensure Compliance of the Global Supply Chain to the most current version of applicable International Medical Product Regulations and Standards through effective implementation, training, and monitoring.
• Support the Global Internal and External Audit Programs including Interface with external agencies as required including the FDA and the Notified Body.
• Collaborate with Global Site Quality Leaders, Global Supply Chain, and Regions to implement digital strategies for Global Supply Chain Quality
• Support Global Quality Management Review for the Global Leadership Team
• Support the installation of a global system for routine review of quality system data, including internal/external audit results to determine compliance gaps and associated mitigation plans on a global level
• Implementation of quality improvement projects about distribution partner management
• Further development of the qualification system for global distribution partners with a focus on medicinal products and medical devices in cooperation with the units responsible for Distribution Partner Management
• Documentation of formal qualification of distribution partners with regard to the commissioned activities (storage, distribution, manufacturing operations, other services)
• Risk-based planning and execution of audits at distribution partners
• Ensure continuous eligibility auditing of international customers and distribution partners
• Assessment of GDP and GMP relevant quality deviations
• Ensure change control processes in cooperation with the responsible Company manufacturing facility and R&D with regards to Distribution activities

Profile:

Minimum 7 years of proven experience in the field of medical devices and/or pharmaceutical products

Degree in Natural science (pharmacy, chemistry, biology) or comparable university degree required.

In-depth knowledge of ISO13485 ISO14971, 21CFR 210,211, 820, European MDR and MDSAP.

Experience in Global Health Authority (including FDA) inspections.

#BOOST\\n \\n \\n \\n \\n \\n

\\n\\n LHH\\n \\n\\n

\\n