Sr Manager, GSRS Quality-Audit and Inspection Readiness

About This Role As the Senior Manager, Audit and Inspection Readiness, you will partner with functional area experts within the SABR and GRA organizations to work as their quality resource to manage audit and inspection readiness activities. Location: Baar, Switzerland working as per our Swiss HR hybrid working policy What You’ll Do

• Develop and continually improve processes to prepare for and manage internal audits and health authority inspections of all Biogen Affiliates, Global Safety and Regulatory Affairs functions.
• Manage the global audit and inspection readiness program for Global Safety and Regulatory functions, including but not limited to:
  • evaluating processes for compliance to regulations
  • leading process improvements
  • preparing SMEs to present their functions during audits/inspections.
• Take a leadership role in managing internal audits and inspections, including hosting or strategy/control room activities.
• Evaluate proposed commitments to audit and inspection findings to ensure timely response and appropriate mitigation.
• Monitor commitments from audit and regulatory inspection findings to ensure accurate and timely completion.
• Provide regular reports to leadership on the status of audit/inspection readiness and commitments.