Director, Clinical Quality Assurance

@ Fulcrum Therapeutics

Company Overview

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases. Their lead program, pociredir, is a small molecule aimed at increasing fetal hemoglobin expression to treat sickle cell disease and other hemoglobinopathies. The company uses a proprietary product engine to modulate gene expression and address root causes of gene mis-expression.

Job Description

The Director, Clinical Quality Assurance will lead program-level Quality Assurance (QA) oversight for clinical studies within Research & Clinical Development at Fulcrum Therapeutics. This role ensures clinical trial activities comply with FDA regulations, ICH guidelines, and international standards. You will oversee CRO qualification and monitoring, manage departmental activities independently, and develop strategies for multiple complex projects aligned with corporate goals and regulatory requirements.

Responsibilities

• Provide quality oversight of GCP compliance, quality systems, and related activities including Quality Risk Management, Data Integrity, audits, and inspections.
• Advise and guide Clinical Trial Teams on GxP compliance, best practices, and regulatory interpretations.
• Lead preparation for and manage regulatory inspections and external audits with CAPA plans and lessons learned.
• Review clinical trial and regulatory submission documentation for completeness and compliance.
• Develop and maintain study-specific audit plans and support GCP/GCLP audits.
• Monitor regulatory changes and communicate impacts to QA staff and Clinical Trial Teams.
• Resolve or delegate resolution of compliance issues at clinical suppliers/sites.
• Implement GxP-compliant procedures to enhance quality management systems.
• Drive continuous improvement initiatives based on audit findings, regulatory updates, and industry best practices.
• Partner with cross-functional teams to review and implement SOPs.
• Deliver training sessions on GCP quality and global regulations.
• Negotiate, monitor, and maintain Quality Agreements with CROs.
• Support clinical and product commercialization activities through quality oversight.

Qualifications

Education & Background: Bachelor's degree in a scientific or allied health field (or equivalent) and a minimum of 10 years’ experience in Quality Assurance including internal and external auditing. Extensive experience with global clinical trial conduct, ICH E6(R3) GCP Guidelines, FDA regulations, and EU requirements is essential along with at least 2 years in a management or leadership role.

Skills & Competencies: Strong leadership, risk-based decision making, cross-functional team collaboration, root cause analysis, audit process expertise, CAPA development, Quality Risk Management, excellent communication skills, and proficiency in project management tools.

Compensation

Base Salary: $200,000—$225,000 USD

Key Skills/Competency

Director, Clinical Quality Assurance, GCP, QA, Regulatory, Compliance, Audit, CAPA, Risk Management, SOPs, CRO