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.   

Remote opportunity 

About this role

As the Manager, Good Clinical Practice (GCP), Quality, Analytics and Data Sciences, you support regulatory compliance and quality related activities including investigation and resolution of study level quality issues, Corrective and Preventative Actions (CAPAs) and ECs across ADS. In addition, you support process development and improvement, risk assessment, creation, and monitoring of Key Quality Indicators (KQIs), Key Performance Indicators (KPIs), trending of CAPAs, investigation of potential Serious Breaches, functional inspection readiness, and internal and external process and vendor audits. In addition, you will manage end-to-end quality deliverables across ADS and ensure that the ADS responsibilities and accountabilities within the Quality Management System (QMS) are supported within ADS.

What you’ll do

• Provide guidance and support to ADS staff on quality and process concerns, regulatory compliance and best practices.  Serve as a liaison between ADS and Research and Development (R&D) Quality and Compliance, Business Process Excellence, and R&D Learning as needed.   
• Support process owners, Subject Matter Experts (SMEs), and cross-functional teams in revision of existing processes or development of new processes. Ensure that all process maps and controlled and uncontrolled documents meet departmental standards and are kept up to date. 
• Facilitate ADS-related internal and external audits and inspections.  Provide leadership, training, and support to ADS inspection teams.  
• Coordinate work of Process Analysts and Technical Writers on completion of process reviews. 
• Conduct Business Process Compliance Reviews in support of process improvement 
• Ensure that training materials and assignments support all processes and adjust as needed to ensure compliance
• Support larger quality investigations done by quality team, including understanding of root cause, discussion with key stakeholders and process owners and conduct of CAPA Effectiveness Checks after larger quality issues are closed.

Who you are

You are (GCP Quality) Analytics and Data Sciences Manager who can develop root cause analysis for quality issue and consult on regulations and best practices for process development.  You can determine if quality issues require a CAPA.  You have a high attention to detail including proven ability to manage multiple, competing priorities.

Required Skills:

• 7+ years relevant work experience in a related position(s) with focus on clinical trial management, and/or Data Management or Statistics or Statistical Programming
• 2-3 years of Quality Issue Management and CAPA experience
• 2-3 years of inspection and audit experience
• Experience developing processes and writing controlled documents
• Solid understanding of drug development and biopharmaceutical industry
• Knowledge of Good Clinical Practice (GCP) and other regulations
• High attention to detail including proven ability to manage multiple, competing priorities

Preferred Skills:  

• Experience coordinating or leading cross-functional meetings (setting the agenda, coordinating the Subject Matter Experts (SMEs) and driving the discussions)
• Project Management Professional (PMP) Certification
• GCP training

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.