Clinical QA Director

New

Skills

Auditing Process improvements

Job Overview

As an Associate Director, Clinical Quality Assurance, you will be responsible for developing partnerships with clinical study teams to identify quality risks across studies. This role involves ensuring QA activities comply with regulations and facilitating internal/external GCP audits to foster data integrity and end-to-end quality across programs. You will also be tasked with identifying opportunities for process improvements, leading clinical inspection readiness, supporting regulatory inspections, and drafting responses to findings.

Responsibilities
  • Develop partnerships with clinical study teams
  • Ensure QA activities comply with regulations
  • Facilitate internal/external GCP audits
  • Foster data integrity and end-to-end quality across programs
  • Identify opportunities for process improvements and CAPA initiatives
  • Lead clinical inspection readiness for assigned programs
  • Support regulatory inspections and draft responses to findings
Requirements & Qualifications
  • BA/BS degree required; advanced degree a plus
  • 8+ years in biopharma R&D with 6+ years in hands-on GCP QA
  • Experience drafting, reviewing, implementing SOPs
  • Knowledge of global regulations/guidance for GCP, GVP, and CSV/A
  • Direct experience conducting internal/external audits and translating findings into corrective actions
  • Working knowledge of Veeva or similar QMS; inspection management tools a plus

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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