Global Supply Chain Quality Manager
vor 2 Wochen
**Global Supply Chain Quality Manager - Based in Western Switzerland**
- Support the development, execution, and delivery of global s**upply 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
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