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.   

As the Associate Principal Quality Analyst, Quality, Process & Training, you will provide support for regulatory compliance, quality, and process activities across Data Management and Biostatistics. 

Accountabilities

• Address compliance requests and questions as assigned
• Lead quality and process related activities including process development and improvement, risk assessment, KQIs, KPIs, CAPAs, inspection readiness, and internal and external audits. 
• Manage end-to-end process, ensuring that all process maps and controlled and uncontrolled documents meet departmental standards and are kept up to date, working closely with process owners, SMEs, Technical Writers, and Business Process Excellence (BPE).
• Ensure that training materials and assignments support all processes.
• Coordinate work of Process Analysts and Technical Writers

• Bachelor’s degree required
• Strong and proven experience of Clinical Data Management and deep understanding of drug development and biopharmaceutical industry
• Expertise in global industry regulations and best practices (e.g. Data Integrity, GCP, 21 CFR Part 11)
• Experience with regulatory inspections and Quality Management Systems
• Experience developing processes and writing controlled documents across the portfolios
• Strong communication, organization, and problem-solving skills
• High attention to detail including proven ability to manage multiple, competing priorities, must have excellent negotiation and problem-solving skills