Biogen Manager, Product Development Quality in Cambridge, Massachusetts
*About This Role * The PDQ Manager is responsible for managing the Quality aspects of Product Development and Commercialization in collaboration with Global Quality, Product Technical Development, Manufacturing, Regulatory CMC, and the Asset team to assure endorsed program deliverables are achieved. This requires management of key functional, tactical, and operational activities to assure all Quality-related aspects of the assigned programs meet the expectations of Biogen’s policies and GMP guidelines. Assigned programs (Assets) may be initially focused on small molecule modalities; therefore, the ideal candidate will have some small molecule technical expertise along with a deep knowledge of GMP guidelines and Quality expectations for drug development. *What You’ll Do * * Supports and manages Quality aspects of product development and commercialization activities for a given product or group of products. Communicates across Quality, PO&T departments, and Asset Team effectively. * Facilitates the execution of Quality activities between Biogen's business partners, the Asset Team, and the Quality organization. Reviews and approves controlled documents, investigational protocols, and reports, change control requests, validation protocols and reports, regulatory submissions, etc., to support assigned programs. * Participates effectively in a membership role for single and multi-site cross-functional teams within PO&T as a representative of Quality as needed. * Performs and facilitates the execution of tactical quality activities in collaboration with the Asset team and Quality organization by leading the Quality sub team for assigned programs. * Effective and transparent planning and communication. Uses effective project management to coordinate Quality and Asset activities related to their programs to assure effective communication and coordination between the Asset team and the Quality organization. * Extracts and uses information from compliance resources and supports program inspections as needed. In depth knowledge of cGMP and ICH guidelines as they apply to clinical and commercial manufacturing and testing. *Who You Are * Do you have experience building excellent relationships across Peers, Managers, and Directors in Global Quality, Asset Team, Product Technical Development, Manufacturing, Regulatory, Global Quality Operations, Quality Control, and Corporate Quality to assure effective assessments are made with the appropriate safety, compliance, and product quality. Are you a strong leader, with effective communication, and collaboration across multiple organizations with proven ability to influence cross functionally to assure objectives are met? A primary quality representative for all aspects of the Asset team. Responsible for communication between the Asset Team and all Quality line functions. Ensures compliance of the program to applicable procedures and highlights areas where a specific product may require changes to current SOPs based on unique challenges. Are you someone who can suggest standard practices, processes, and procedures for group/department/program? Participate in key strategic initiatives beyond direct program affiliation and identify potential improvements in inter-departmental business practices and participates in implementation of improvements. *Required Skills * * 8 years (BS), 6 years (MS), 4 years (PhD) experience in Quality or deep familiarity with Quality requirements through hands-on experience * Experience in pharmaceutical-related development. * Technical expertise in manufacturing, testing, and/or technical development is a plus * Proven experience in working cross functionally, leveraging their skills to influence and drive results within the matrix organization * Exceptional team player and ability to develop strong network across the company and with external partners as needed * Project Management skills *Why Biogen? * Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.