At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine.

“This is a US Remote Oppotunity" 

About this role

As the Sr. Principal/Manager, Analytics and Data Sciences (ADS) Quality, you will provide leadership for compliance and quality activities across ADS.  You are responsible for addressing compliance requests and questions, for ensuring inspection readiness, and for providing quality and compliance training to the ADS department.  You play a pivotal role supporting closure of the most complex and important regulatory agency commitments and CAPAs specific to ADS.  You consult and provides guidance for other departments on ADS specific quality regulations, expectations, and best-practices.

What you’ll do

• Provide guidance and support to ADS staff in the area of regulatory compliance and best practices.  Serve as a liaison between ADS and R&D Quality, Operations and Performance.  Assist with CAPAs, Memos to file, deviations, and other compliance related items. Maintain expertise in regulations, guidance and best practices related to data integrity and all ADS activities.
• Coordinate ADS-related internal and external audits and inspections.  Provide leadership, training, and support to inspection teams. Support closure of regulatory agency commitments and CAPAs specific to ADS.
• Lead and/or contribute to ADS and cross-functional initiatives related to quality and compliance.  Participate in the identification of gaps in process or documentation and leads teams to implement solutions.
• Provides training on regulations, expectations, and best-practices.

Required Skills:

• Bachelor’s degree required, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• 10+ years relevant work experience in related position(s) with a focus on data management and/or data analysis
• Expertise in global industry regulations and best practices (E.g. Data Integrity, GCP, 21 CFR Part 11)
• Experience with regulatory inspections
• Experience with Quality Management Systems
• Deep understanding of drug development and biopharmaceutical industry
• High attention to detail including proven ability to manage multiple, competing priorities, must have excellent negotiation and problem-solving 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.

All your information will be kept confidential according to EEO guidelines.