Global Clinical QA Director: Strategy & Compliance

4D Molecular Therapeutics; United States; On-site; USD 245,000 - 286,000; Full time

Job summary

4D Molecular Therapeutics in the United States seeks a Senior Director of Clinical Quality Assurance to lead global registrational trials and ensure GCP compliance. You will guide QA strategy across vendors, drive risk-based audits, CAPA, and inspection readiness while mentoring staff and collaborating with cross-functional teams.

The role requires extensive biotech experience, with ophthalmology exposure preferred, and strong executive communication to align senior stakeholders and drive

Qualifications

• 12+ years in regulated environments such as biotech or pharma.
• Experience leading global clinical quality strategy and governance.
• Proven ability to influence senior stakeholders.

Responsibilities

• Provide strategic QA leadership for registrational global clinical trials.
• Develop Clinical Study Quality Plans and risk-based oversight.
• Oversee CAPA process and inspection readiness.
• Manage QA staff and consultants.
• Collaborate with cross-functional teams across Clinical, Regulatory, and Quality.

Skills

Strategic quality leadership

GCP/Audit experience

Interpersonal/communication

Mentorship/people leadership

Education

Bachelor's degree in life sciences or related field

MS/PhD/PharmD preferred

Job description

4D Molecular Therapeutics in the United States seeks a Senior Director of Clinical Quality Assurance to lead global registrational trials and ensure GCP compliance. You will guide QA strategy across vendors, drive risk-based audits, CAPA, and inspection readiness while mentoring staff and collaborating with cross-functional teams.

The role requires extensive biotech experience, with ophthalmology exposure preferred, and strong executive communication to align senior stakeholders and drive