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Sr Associate, Audit & Vendor Management Durham United States,  

Posted on : 23 May 2017

Project Description

External Posting TitleSr Associate, Audit & Vendor Management Job DescriptionThe Sr. Associate helps ensures that Biogen GMP operations are being conducted in compliance with worldwide regulatory requirements and all applicable procedures and corporate standards. This is accomplished through assessing and auditing suppliers, partners, service providers, and internal systems1. Plans and conducts audits to confirm that suppliers, partners, service providers, and internal systems operate in accordance with GMP and other applicable worldwide regulatory requirements, and in compliance with Biogen requirements and expectations.2. Document audit observations and evaluate their potential impact. This would include evaluating responses to audit findings and ensuring that completed audit reports and responses are maintained for future reference and analysis.3. Collaborate with internal customers to determine appropriate courses of action to take in response to vendor related concerns.4. Facilitate maintenance of audit databases.5. Reviews audit program Standard Operating Procedures as needed*LI-GA3 LocationResearch Triangle Park, NC, US Job CategoryQuality Requisition Number31432BR QualificationsProficiency in MS Word, MS Excel, MS PowerPoint, and MS Outlook required. Proficiency in TrackWise preferred. Excellent oral and written communication skills and detail-oriented aptitude required.Minimum of 5+ years in pharmaceutical/regulated industry or 3+ years in Quality/Compliance with auditing responsibilities EducationBachelor's degree required, preferably in Life Sciences or Engineering About BiogenCorporate OverviewThrough cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen 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). Biogen 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.Biogen was founded in 1978 and today serves patients in nearly 70 countries. A Fortune 500 company, Biogen in 2016 had revenues of $11.4 billion Global headquarters in Cambridge, MA, and international headquarters in Zug, SwitzerlandOur ScienceWe 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 Biogen 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, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.Biogen is revolutionizing biologics manufacturing, developing the industry s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.Our Corporate CitizenshipThe 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. In 2015, we became a carbon neutral company and ranked first place on Newsweek s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.Please be advised that all legitimate correspondence from a Biogen employee will come from "" email accounts. Job Segment: Audit, Biotech, Manager, Engineer, Pharmaceutical, Finance, Science, Management, Engineering


Research Triangle Park NC US

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