Risk Specialist, Clinical Quality Assurance

Arrowhead Pharmaceuticals
Verona, CA
Category Data Analyst
Job Description
Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing RNAi therapeutics for intractable diseases. The Risk Specialist, Clinical Quality Assurance, will support the development and maintenance of the Risk Management Platform, contribute to GCP data analytics, and assist with computer system validation. This role requires data-driven insights and operational support to ensure GCP compliance and data integrity.

Requirements

  • Support and contribute to risk management analysis efforts associated with GxP functions (primarily GCP).
  • Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level.
  • Identify KPIs involved with risk monitoring from internal and external sources.
  • Assist and contribute to the development and maintenance of the Risk Management Platform.
  • Consume, classify, and integrate external and internal data into the Risk Management Platform.
  • Assist with platform and tool research associated with the implementation and advancement of the Risk Management Platform.
  • Train and assist members of the Quality Assurance and Clinical Operations and Development teams.
  • Participate in the generation, training, evaluation, and execution of Arrowhead Standard Operating Procedures and Work Instructions.
  • Issuance, review, tracking, and completion of deviations and CAPAs.
  • Understand and comply with Food & Drug Administration (FDA), European regulations, and ICH guidelines.

Benefits

  • Competitive salaries
  • Excellent benefit package
]]>