BrightOwl Loader Loading

Sr. Associate for Quality Assurance, Systems & Support Hillerød Denmark,  

Posted on : 25 April 2017

Project Description

External Posting TitleSr. Associate for Quality Assurance, Systems & Support Job DescriptionDo you want to work for a company that develops, markets and produces medicine that help patients all over the world suffering from diseases such as Multiple Sclerosis, Alzheimers, and Parkinsons? And do you thrive in a role where you will provide oversight and direction for review and approval of GMP-related documents and records that support manufacturing and clinical operations? Then the opportunity as Sr. Associate in Biogen s Quality Assurance Systems & Support team might be your next step.The Quality Assurance Systems & Support department consists of two teams which are characterized by working dedicated together and with counterparts across Biogen s subsidiaries globally; the Record Lifecycle Management (RL) team and the Quality Management System (QMS) team. You will work in the QMS team with five colleagues on issuing documents, archiving, and routing new documents including improving the process and system knowledge behind. You will also be a central player during prep and hosting of Audits and Inspections. Many of us have been with Biogen for some time and we all look forward to welcoming a new colleague who will also contribute to the positive spirit and dedicated approach that characterize our team. We are also open to bringing a colleague in who has an eye for process improvement and can help us develop features and flows that will make our work easier in the long-term. Thus, we offer you to take part in driving our effort to increasingly digitalize our processes; perhaps even drive some of the department s projects yourself. Accountabilities:The principal accountabilities of this job are to:• Facilitate the document change control process from initiation through document effectivity. Review and may provide final Quality approval of Standard Operating Procedures (SOP s), Forms, Master Production Records (MPR s), and Solution Lot Records (SLR s) related to Manufacturing/Packaging operations• Provide training to Site personnel on departmental SOP s, Quality Systems documents and Qualifying Events as related to QA• Provide QA representation and guidance for manufacturing on issues related to Documentation and Compliance. Provide technical assistance to manufacturing operations as related to compliance requirements• Lead department projects and participate in Global Documentation Quality system teams/projects and devise implementation plans• Develop, review and implement improved practices and procedural-based documents. Demonstrate ability to resolve issues with customers independently with a commitment to customer service. Revise and perform biennial review of procedural-based documents• Lead internal/self-inspection audits to assure cGMP compliance. Provide QA support and representation for documentation procedures during Regulatory inspections.*LI-DEN2 LocationHillerod, Denmark Job CategoryQuality, Operations, Technology & Innovation (PO&T) Requisition Number30780BR QualificationsMinimum 5-8 years of experience in a regulated environment. It is a plus if you have an ASQ certification or an ISPE, PDA membership or equivalent. You demonstrate experience in working in a Quality Management System.Fluency in English is required; ability to speak and write Danish is a plus. EducationYou have a BA degree in a science, IT or a relevant business discipline.The deadline for this position is Tuesday 16 May 2017, but we are assessing candidates on an ongoing basis.If you have any questions about the position, please contact Talent Acquisition Partner, Rikke Nissen +45 7221 8920. About BiogenThrough cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today has the leading portfolio of medicines to treat multiple sclerosis, 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. Biogen also manufactures and commercializes biosimilars of advanced biologics. With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. With a strong affiliate presence and a network of distribution partners, Biogen has established a global footprint that allows us to capture the greatest value for the products we develop. 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: Biotech, QA, Quality Assurance, Quality Manager, Science, Quality, Technology


Hillerod Denmark

Find a Job Find Candidates

Most Recent Searches

Most Famous Searches

You might also like