About This Role

As the Seniorr Manager, R&D Pharmacovigilance Quality, 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.   

**We will consider candidates located in Switzerland and the Netherlands**

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
• May manage one or more QRM team members supporting QRM’s accountabilities
• Supports local/regional Health Authorities Inspections and responses to Regulatory Authorities
• 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.
• Serves as an independent point of quality escalation to the business, and maintains an holistic picture of GVP quality by identifying, assessing, advising on and overseeing mitigation of impactful quality risks, providing input into R&D Quality & Strategic Operations (QSO) leadership and quality leads within R&D functions regarding needs / actions. Contributes to/leads assessments of GVP/GxP related quality issues
• 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 the Regulatory Intelligence program
• Contributes to the Quality Risk Management Program 

Who You Are

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

#LTD-1

Required Skills

• Bachelor’s Degree within life sciences
• 5+ years, GVP, GCP or GMP 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

 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.