Global Quality Compliance Manager - Urgent Position

We are looking for a confident Global Quality Compliance Manager to join our stellar team at LHH in Lausanne VD.
Growing your career as a Full Time Global Quality Compliance Manager is an incredible opportunity to develop relevant skills.
If you are strong in cooperation, teamwork and have the right mindset for the job, then apply for the position of Global Quality Compliance Manager at LHH today!

For one of our clients, an international company in Canton de Vaud, we are looking for a Global Quality Compliance Manager

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:

 

Bachelor’s Degree or Equivalent, Master’s Degree Preferred

Minimum 5 years of proven experience in the field of medical devices

Knowledge of applicable ISO Standards ISO13485, ISO 9001, ISO14971, the Medical Device Directive 93/42/EEC, 2017/745 Medical Device Regulation other relevant European directives, general knowledge of US Quality System Regulations and other applicable Country regulations worldwide

#BOOST

Benefits of working as a Global Quality Compliance Manager in Lausanne VD:

● Learning opportunities
● Opportunities to grow
● Attractive package