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Manager, Quality Operations International Lausanne Switzerland,  

Incyte (company)

Posted on : 12 June 2017

Project Description

The Manager, QA Operations International will be responsible for the regular Quality of manufacturing activities to ensure compliance of our company commercial Products, with a primary focus on API (Active Pharmaceutical Ingredients) manufacturing. 

Duties and Responsibilities 
  • Manage the day-to day quality oversight of International CMOs involved in API manufacturing 
  • Direct the Validation activities for the introduction of new CMOs/new Products  
  • Ensure compliance of our company Products by reviewing, approving and ensuring maintenance of Material and Product specifications, 
  • Perform Batch Record Reviews and releases, 
  • Manage Manufacturing deviations, 
  • Ensure and monitor implementation of Changes at assigned CMOs 
  • Ensure and monitor implementation of CAPA at assigned CMOs  
  • Perform external and internal audits according to our company  audit program; 
  • Participate to the elaboration of APR and PQR and coordinate collect of data with assigned CMOs. 
  • Support the CMC group for regulatory submissions 
  • Manage API shipping validations in collaboration with Supply chain teams 
  • Manage Quality and Technical Agreements with assigned CMOs 
  • Contribute to define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to manufacturing; 
  • Ensure inspection readiness for PAI at assigned CMOs 
  • Participate to the inspection readiness of the company  Bio-sciences International Site 
  • Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensure implementation as applicable, 
  • Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements 
  • Stay current with the applicable regulations and promote Quality across the organization 
  • Act as back up of the Manager QA Operations Drug Product 

Company Culture
  • Contribute positively to a strong culture of business integrity and ethics  
  • Act within compliance and legal requirements as well as within company guidelines 

  • Academic degree in Chemistry or Pharmacy; 
  • Firsthand experience of min 5 years in Quality Operations in API manufacturing for international pharmaceutical industry, ideally acquired at a manufacturing site  
  • Experience of solid oral dosage forms and aseptic manufacturing is an asset; 
  • Thorough knowledge in cGMP and global regulatory requirements; 
  • Experience in Validation and tech transfers; 
  • Qualified auditor; 
  • Experience in dealing with Contractors; 
  • Strong Interpersonal skills;  
  • Strong verbal and written communication skills with well-structured communication and technical writing ability 
  • English fluency written and spoken (the company language), German and French are an asset; 
  • Travel up to 20% 
  • Results focused with good interpersonal skills, diplomacy, negotiation skills and common sense 



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