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Sr. Product Complaints Specialist (QA) Zug Switzerland,  

Biogen (company)

Posted on : 10 July 2017

Project Description

Job Description 
  • Provide subject-matter expertise in our company's Technical Product Complaint function as it pertains to product related customer complaints, ensuring compliance with regulatory standards for the markets in which the company's product are manufactured and distributed.  
  • You are expected to lead projects independently, initiate and implement changes and improvements. 
  • This role assumes shared administrative responsibilities for relevant software applications, training and development of the team members. 
  • The holder of the position acts as backup for the department head and may evolve into managing a team of 4 to 8 people.

  • Reviews and approves cases, ensuring global consistency and compliance etc. 
  • Oversee and develop a risk based and data driven complaint system
  • SME on regulatory and quality requirements. Ensure SOPs alignment with regulations and global procedures, directives and SOP of other departments
  • Supervise case investigation, monitoring correct CAPA follow up for established root cause
  • Establish internal and external sample investigation capability that meets the need of future products
  • Develop and maintain a global process for detection and testing of falsified medicines
  •  Coaches team members and provide constructive feedback on cases
  • Performs metric reporting  including those related to assigned CMOs, partners, supplier review meetings and audits
  • Identify meaningful KPI for stakeholders/ process and maintain a system to capture and monitor them.
  • Ensure adequate communication on data trending, critical cases to impacted groups and senior management
  •  Participate in partner management review meetings

  •  2-4 years' work experience in quality or technical product complaint function 
  • Proficient in Word, Excel, PowerPoint
  • Fluent English (written and spoken) is a must
  •  GMP knowledge
  • CAPA 

Bachelor or Master in Life Science or Engineering. 

About Us 
  •  Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. 
  • Our company  is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS).  
  • Our company  also manufactures and commercializes biosimilars of advanced biologics.   
  • Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.  
  • Our company  was founded in 1978 and today serves patients in nearly 70 countries.  

 Our Science 
  •  We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.  
  • To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.  
  • For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. 
  •  Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. 
  • We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS. 
  • As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.  
  • Our company  is revolutionizing biologic manufacturing, developing the industry s most advanced plants and processes. 
  •  This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.  

  Our Corporate Citizenship 
  •  The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. 
  •  As a company, we are focused on improving science education and limiting the impact of our company on the environment. 

Job Segment:  Biotech, CAPA, Engineer, Science, Management, Engineering, Research, Customer Service                       


Zug Switzerland

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