About This Role

As the Senior Manager, R&D GVP Quality and Compliance, you will partner with quality and compliance functions and work with subject matter experts (SMEs) to maximize the value of each audit, drive complex multi-functional CAPAs, execute the regulatory intelligence, quality risk management and change control processes.  Additionally, you will provide support for inspections and participate in other quality risk management activities across R&D.   

Note: this role is not responsible to conduct audits.

 What You’ll Do

• Provides input into the GVP/GxP annual audit strategy and annual audit plan
• Oversees the planning, conduct, approval, and close-out of audits performed by contract auditors for GVP/GxP audits
• Oversees the execution of the end-to-end audit processes to ensure the coordination and execution of audit scope and follow-up activities with relevant stakeholders
• Provides subject matter expertise (SME) in the development and review of procedural documents related to Quality Assurance processes such as audit, CAPA and Quality Issue Management, quality risk management and observational trend analysis, etc.
• Contributes to identification of relevant GxP trends and supports process improvement initiatives to implement process changes to address any gaps or inefficiencies
• Contributes to/leads assessments of GVP-related quality issues
• Participates in the CAPA management process including direct or indirect implementation of actions resulting from inspections observations and quality issues, reviewing and approving CAPA responses, etc.
• Coordinates and/or facilitates quality risk management activities at the process level across R&D
• Coordinates and/or facilitates the GVP Regulation monitoring, assessment, and implementation process
• Supports local/regional Health Authorities Inspections and responses to Regulatory Authorities etc.

Who You Are

We are looking for someone who is passionate about Quality, loves to learn, and enjoys collaborating with many different functions.

Required Skills

• Bachelor’s Degree within life sciences
• 5+ years, GVP and/or QA or Compliance experience
• Experience in any of the following areas: audits, inspection management, inspection readiness, CAPA management, quality risk management or related quality management system responsibilities
• Working knowledge and solid understanding of the GxP drug development regulations including USA (FDA), EU (EMA and MHRA), Japan (PMDA), ICH Guidelines and general compliance

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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.