Director, Clinical QA

Scorpion Therapeutics; United States; Remote; USD 180,000 - 250,000; Full time

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

Role:

Head of Clinical Quality Assurance at Neurocrine Biosciences, responsible for developing and executing the clinical QA strategy, establishing compliance frameworks, and leading a team of QA professionals.

Core Responsibilities:

• Overseeing GCP compliance
• Managing internal and external audits
• Supporting regulatory inspections
• Enhancing the clinical Quality Management System across Phase I-IV trials, with a focus on neuroscience and related therapeutic areas.

The role involves collaboration with Clinical Development, Regulatory, Drug Safety, and Clinical Operations teams to ensure adherence to global GCP/regulatory standards and facilitate regulatory submissions.

Requirements:

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

Preferred Qualifications:

• Recognized thought leadership, advanced knowledge of FDA/EMA regulations, and experience with biological, gene therapy, or neurological programs.

High-Value:

Leadership in clinical QA within biotech/pharma, GCP compliance, experience with multi-phase clinical trials, regulatory inspection readiness, and global QA systems.

The position is based remotely, with a focus on building a strong quality culture across functions.