stillingsbetegnelse: Corporate Quality Operations Specialist

jobbeskrivelse:
External Posting Title Corporate Quality Operations Specialist Job Description Biogen in Hillerød is looking for a Corporate Quality Operations Specialist who will support operational aspects of Corporate Quality Globally. As a Corporate Quality Operations Specialist you will interact on a cross-site and cross-departmental level to drive processes forward including Vendor Change Management, Vendor Management, and Supplier Complaints processes. You will actively participate in the prioritization of the groups work load based on business need and compliance. You will serve as the Change Owner of Change Plans and Orders and the Investigator for Supplier Complaints. As the Change Owner you are expected to coordinate the assessment of VCNs and the execution of all action items stemming from Change Orders with impacted personnel. The Corporate Quality Operations Specialist will have responsibility to perform Supply Complaint and other investigations independently and implement effective CAPAs for failures of business processes associated with the management VCNs and Supplier Complaints. You will have cross-site and cross-departmental interaction with peers to ensure timely communication of issues in support of manufacturing initiatives and to maintain harmonization of procedures and methods, as appropriate. Main tasks • Plan, implement and direct operational aspects of Corporate Quality with respect to VCNs, Supplier Complaints and Supplier Management • Provide technical support as well as facilitation of investigations • Manage the implementation of Vendor Changes and manage the investigation and resolution of Supplier Complaints • Provide sound technical review for documentation to support change management of GMP items • Participate effectively in a leadership or membership role for cross-site and cross-functional teams as a representative of the Corporate Quality. • Support development and enhancement of the Quality Systems that govern GMP items Location Hillerod, Denmark Job Category Quality Requisition Number 27254BR Qualifications Qualifications Professional skills You have a minimum of 5 years of relevant experience in the pharmaceutical or biotech industry or other regulated industries. As a Corporate Quality Operations Specialist you possess expert level knowledge regarding Quality systems and business processes associated with the management of VCNs, Supplier Complaints, and/or vendor management. You have experience with investigation and CAPA and knowledge of USP/PhEur/JP regulations and compliance. You have excellent English skills and solid computing skills. Personal skills You have demonstrated leadership abilities and are able to work effectively and independently within the group, site and across all sites and levels of the organization. This requires excellent written and verbal communication skills and the ability to plan work based on the actions and lead times necessary to accomplish the task. You need to be able to communicate with management, peers, Vendors, Suppliers and External Contractors effectively in a timely manner. You have strong organizational skills and are good at multi-tasking and coordinating multiple activities in parallel. You have demonstrated problem solving and troubleshooting skills. Education You have a Bachelor or Master Degree within Science Application Please apply online. Your application and CV must be in English. As applications are reviewed on a daily basis you are encouraged to submit your application as early as possible. About Biogen Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is one of the world’s oldest biotechnology companies. Our development pipeline is focus

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark