Associate Director, Clinical Quality Compliance
Remote / Online - Candidates ideally in
San Jose, Santa Clara County, California, 95199, USA
Listed on 2026-10-09
San Jose, Santa Clara County, California, 95199, USA
Listing for:
Scorpion Therapeutics
Remote/Work from Home
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
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.
- 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
- 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
- advanced degree
- trial systems expertise
- experience as Functional Quality Representative
- regulatory inspection management
- 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.
Position Requirements
10+ Years
work experience
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