Global Quality Compliance Manager – Based in Western Switzerland 

Missions

• Collaborate to ensure Compliance of the Global QMS 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. 
• Partner with Global Regulatory Affairs to assure integration of Regulatory Intelligence activities and changing expectations into the QMS
• Support the development, execution, and delivery of global quality compliance strategies.
• Partner with Quality Site Heads, Global Quality Functions, R&D, Supply Chain, Operations & Marketing to assure Global Compliance Objectives are identified and fulfilled.
• Drive continuous improvement in the overall compliance profile
• Continually evaluate the site 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 GMP requirements.
• Support the development of company-wide Quality compliance roadmap and define priorities in line with global requirements and existing compliance gaps including the development, installation and monitoring of Global Quality Policies and Procedures
• Collaborate to define global processes & support the site Quality Heads to ensure execution on site level, supporting the site leaders as needed
• Facilitate the harmonization of quality compliance standards and ensure they are aligned across functions
• Collaborate with Global Site Quality Leaders to implement digital strategies for Global Quality and Compliance Data
• 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

Profile:

• Minimum 5 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.

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