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Sr Manager, Drug Safety Quality - Process and Records Management - United States  

Biogen (company)


Posted on : 23 May 2017

Project Description

Job Description
  • The Process and Records Management Senior Manager provides direct supervision to the Process and Records Management Managers and Associates and will liaise and collaborate with Development Sciences and functions to:
  • Ensure SABR is implementing and adhering to Development Sciences Business Processes requirements
  • Ensure a comprehensive training system governing the global PV systems in Collaboration with R&D Compliance, Corporate Quality and SABR management to develop and implement effective training programs and efficient training delivery and tracking mechanisms
  • Ensure a Records and Knowledge Management system is in place and consistent with R&D compliance documentation systems and in line with PV regulation worldwide
  • The Process and Records Management Manager will also be responsible for overseeing the development and management of the PSMF
  • Provide direct supervision and management of Process and Records Management Associates (including mentoring)
  • Ensure SABR is implementing and adhering to Development Sciences Business Process requirements
    • Ensure appropriate assignment of process and sub-process owners and provide support
    • Provide oversight over change management for process implementation or update
    • Provide technical writing expertise for SABR process owners and sub-process owners
  • Ensure SABR is implementing and adhering to Development Sciences Business Learning requirements
    • Ensure SABR functions have clear training requirements
    • Oversee SABR course catalogue and manage training quality
    • Ensure proper development and delivery of required trainings 

  • 5 - 7 years experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences
  • Minimum of 3-4 years management and / or project management
  • Knowledge of FDA expectations is essential
  • Knowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations
  • Direct experience in GCP compliant quality systems
  • Regulatory affairs, quality assurance or clinical departments experience is preferred 

Master’s level degree (or Bachelor’s Degree with relevant experience) in medical or life sciences or the equivalent experience 

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. 

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