Senior Manager, Product Development Quality

Job Description

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 (Quality Product Lead).  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 Biologics technical expertise along with a deep knowledge of GMP guidelines and Quality expectations for drug and biologic development. 

*This role may be based in Cambridge, MA or RTP, NC locations and this is a hybrid role which requires part-time work on-site*

What You’ll Do as a Quality Product Leader

• Supports and manages Quality aspects of product development and commercialization activities for a given product or group of products
• Communicates within Quality, PO&T departments, and CMC Asset Team effectively
• Facilitates the execution of activities between business partners, the CMC Asset Team, and the Quality organization
• Approves controlled documents, protocols, and reports, change control requests, validation protocols and reports
• Acts as the final approver for regulatory submissions
• Contributes 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
• Provide input and guidance into more complex programs/activities and unique stage-gate requirements
• Actively mentors colleagues

Qualifications

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?
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 
•    Bachelors (STEM preferred) plus 7 years of experience in Quality / deep familiarity with Quality requirements through hands-on experience; or
•    Masters (STEM preferred) plus 5 years of experience in Quality / deep familiarity with Quality requirements through hands-on experience; or
•    PhD (STEM preferred) plus 3 years of experience in Quality / 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

Preferred Skills
•    Technical expertise in manufacturing, testing, and/or technical development is a plus
 

Additional Information

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.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.