Compliance Manager R&D - Mountain View, CA | Biospace
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Compliance Manager R&D

MedImmune, LLC

Mountain View, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

                                       Location:Mountain View, California, United States
Job reference: R-006700

Posted date: Apr. 27, 2017



   If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.  

   MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Compliance Manager – R&D in Mountain View, CA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  

And we’re excited to share that our work at the Mountain View site (along with some other AstraZeneca Group Companies in the Bay Area) will relocate to South San Francisco by end of 2017.  
Click here
for more information on this new facility.

   We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.  

   MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.  

   Main Duties and Responsibilities  

   As Compliance Manager R&D, you will be responsible to provide GLP and lab GCP compliance system support to the Translational Sciences (TS) function and actively participates in development of Quality mindset within the TS organization. You will advise and advocate to ensure regulatory compliance and continued inspection readiness through quality systems; Champion and drive quality mindset across Translational Sciences and GLP support groups; Be responsible for Research Validation program; Develop and implement effective quality systems, author and review SOPs and other documents.  

   Additionally, you take initiative, be assertive, and lead by example and builds relationships.  You will maintain constant collaborative interactions with co-workers across functional groups and Departments;  Maintain knowledge of GLP regulatory requirements (FDA and OECD), current industry trends, standards and methodologies as it relates to GLP/GCLP regulated activities; Support compliance of individual functional areas as assigned; Present on quality issues, initiatives and projects at cross-functional meetings.  You may have additional responsibility for Corporate HBS compliance and act as Back-up GLP Archivist.  


   Essential Requirements  

  •      BS/BA in Biological Sciences or related field    
  •      Minimum 5 years experience in biopharmaceutical/pharmaceutical industry in lead QA or Compliance related role    
  •      Strong understanding and current knowledge with global GLP regulations and guidelines    
  •      Excellent written communication including strong background authoring documents in support of regulatory compliance    
   Desirable Requirements  
  •      Excellent verbal communication and interpersonal skills, including ability to forge strong relationships and influence others across business disciplines and all levels of the organization    
  •      Strong experience identifying compliance issues, root cause, impact analysis and effective corrective actions.    
  •      Strong experience applying critical thinking and problem solving to compliance issues.    
  •      Strong organizational and analytical skills including prioritization and time management    
  •      Ability to adapt to changing business priorities and challenges    
  •      Experience with process improvement tools and methodologies a plus    
  •      Proficient with MS Office (Word, Excel, Visio)    

   Next Steps – Apply today!  


   To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.  

   AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.