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Investigations Manager Hillerød Denmark,  

Biogen (company)

Posted on : 04 July 2017

Project Description

Job Description
  • Our company  is looking for a Regional Investigations Manager who will be accountable for maximizing organizational learning and improvement from high-risk Quality and Safety events. 
  • Our new Regional Investigations Manager will head up a newly established team of 3 investigation associates, and will have responsibility for growing this team to full capacity.  We expect the team, once all positions have been filled, to consist of approximately 6-7 investigations associates.
  • As Regional Investigations Manager, you will engage closely with a range of stakeholders to ensure actions that are taken as a result of events prevent or mitigate the risk of future recurrence.
  •  It is your role to ensure that analytical cause analysis techniques and organizational performance principles are applied.
  •  Since these methods are new to our company , it will be critical to have excellent coaching and relation building skills.
  • The Regional Investigations Manager will  work closely with the operations team in Switzerland, which is our next-generation manufacturing plant currently under construction.
  •  It is anticipated that the Regional Investigations Manager will need to provide on-site support  approximately 1-2 days on a monthly basis beginning in early 2018.
  •  Your input will also be needed to design the best possible investigations model for Southern in the long run. 
  • You will report to the US-based Director of Human Performance.

The principal accountabilities of this job are:
  • Lead regional team with responsibility for conducting and documenting Quality and Safety investigations.  
  • Ensure Quality and Safety investigations are conducted with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations.
  • May directly support and/or conduct complex and/or high impact investigations.    
  • Manage team workload to ensure investigation standards and due date requirements are met.  
  • Grow and develop the skills of the team.  
  • Provide guidance for our company's investigations standards.
  •  Coordinate internal sharing of investigational findings and risk knowledge 

  • Min. 5-8 years of experience in a lab or operations environment (industrial/plant experience preferred) 
  • Experience within the investigations area
  • Leadership experience a plus; but not a requirement 

B.S./Master s degree in Engineering, Biology, Chemistry, Organizational Psychology, or a related scientific discipline.

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, Engineer, Quality Manager, Biology, Manager, Science, Engineering, Quality, Management                       


Hillerod Denmark

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