About This Role
This role is responsible for managing the Quality aspects of Product Development and Commercialization in collaboration with Global Quality, Technology Development, 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 biologics modalities; therefore, the ideal candidate will have some biologic technical expertise along with a deep knowledge of GMP guidelines and Quality expectations for drug and biologic development.
What You’ll Do
Support and manages Quality aspects of product development and commercialization activities for a given product or group of products.
Communicate within Quality, PO&T departments, and Asset Team effectively
Facilitate the execution of activities between business partners, the CMCAsset Team, and the Quality organization.
Approve controlled documents, protocols, and reports, change control requests, validation protocols and reports,
Act as the final approval for regulatory submissions
Additional responsibilities for Sr. Manager:
Contribute to regulatory strategic plan in addition to final approval for regulatory submissions
Able to delegate/empower cross-functionally as part of execution of activities
Strong communication skills as per above but also able to influence more effectively and escalate issues appropriately
Actively mentors colleagues
Provide input and guidance into more complex programs/activities and unique stage-gate requirements
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.
Manager, Product Development Quality:
5-7 years (BS), 3-5 years (MS), 2-3 years (PhD) experience in Quality or deep familiarity with Quality requirements through hands-on experience
Sr. Manager, Product Development Quality:
7-10 years (BS), 5-7 years (MS), 3-5 years (PhD) experience in Quality or deep familiarity with Quality requirements through hands-on experience
Experience in pharmaceutical-related development
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
Technical expertise in manufacturing, testing, and/or technical development is a plus
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.