Remote Director, Clinical QA & Compliance

Scorpion Therapeutics

United States

Remote

USD 180,000 - 250,000

Full time

14 days+
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Benefits offered by this job

Remote work
Leadership role in biotech QA

Job summary

Neurocrine Biosciences is seeking a Head of Clinical Quality Assurance to develop and execute the clinical QA strategy and lead a team of QA professionals. You will collaborate across Clinical Development, Regulatory, Drug Safety, and Clinical Operations to ensure global GCP compliance and inspection readiness.

The role emphasizes building a strong quality culture across functions, overseeing multi-phase trials, and enabling successful regulatory submissions in neuroscience programs.

Qualifications

  • RN, BSN, BS/MS, or BA with 12+ years of industry experience in GCP environments, including extensive audit and inspection expertise; managerial experience necessary.

Responsibilities

  • Overseeing GCP compliance across trials and functions.
  • Managing internal and external audits to ensure readiness and findings closure.
  • Supporting regulatory inspections and agency interactions to facilitate submissions.
  • Enhancing the clinical Quality Management System across Phase I–IV trials, with a focus on neuroscience and related therapeutic areas.

Skills

GCP compliance
Auditing
Regulatory inspections
Leadership

Education

RN/BSN/BS/MS/BA with 12+ years in GCP

Job description

Neurocrine Biosciences is seeking a Head of Clinical Quality Assurance to develop and execute the clinical QA strategy and lead a team of QA professionals. You will collaborate across Clinical Development, Regulatory, Drug Safety, and Clinical Operations to ensure global GCP compliance and inspection readiness.

The role emphasizes building a strong quality culture across functions, overseeing multi-phase trials, and enabling successful regulatory submissions in neuroscience programs.

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