Associate Director, Clinical Quality Compliance

Role: Associate Director, Clinical Quality Compliance at Biogen, serving as a strategic quality leader within R&D Quality & Compliance to ensure GCP adherence and a culture of quality across clinical development. Responsibilities: oversee Vendor Quality Governance, lead clinical study quality oversight, support QMS improvements, manage investigations, CAPA, and inspection readiness; partner with internal teams and vendors to mitigate risks and ensure compliance with global regulations; monitor quality metrics and drive continuous improvement initiatives. Requirements: bachelor’s degree in a scientific or healthcare discipline; 10+ years in Clinical Operations, Quality, or Compliance within pharma/biotech; extensive GCP knowledge, experience with investigations, vendor oversight, and regulatory inspections; strong leadership, analytical, and stakeholder management skills. Preferred: advanced degree, trial systems expertise, experience as Functional Quality Representative, and regulatory inspection management. HighValue: clinical development, GCP compliance, vendor governance, investigations and CAPA, inspection readiness, risk management; location ideally within Eastern or Central Time Zones; remote work with no travel specified.