CSL

Director, Clinical Compliance

CSL

full-time

Posted on:

Location Type: Hybrid

Location: King of Prussia • Pennsylvania • United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Develop processes, systems and standards for inspection readiness in clinical studies
  • Manage internal quality processes for compliance with quality standards
  • Drive implementation of the Quality Management System (QMS) Framework
  • Lead development of study level quality risk management plans
  • Integrate Clinical Compliance Management (CCM) into Study Execution Teams (SET)

Requirements

  • Degree (BSc/MSc/Diploma) in scientific/medical/pharmaceutical discipline
  • 10+ years of professional work experience in a Clinical Development/Research environment
  • Extensive understanding of the clinical research and drug development lifecycle
  • 3+ years of line management experience
  • Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directive
Benefits
  • Health insurance
  • 401(k) plans
  • Paid time off
  • Flexible work arrangements
  • Professional development
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality Management System (QMS)Clinical Compliance Management (CCM)Quality risk managementInspection readinessClinical researchDrug development lifecycleICH GCPFDA GCP RegulationsEU clinical trials directive
Soft Skills
LeadershipManagementOrganizational skills
Certifications
Degree in scientific disciplineDegree in medical disciplineDegree in pharmaceutical discipline