Global Quality Assurance Director (Biopharma)

Qpex Biopharma Inc in; San Diego (CA); On-site; USD 200,000 - 240,000; Full time

Job summary

Qpex Biopharma Inc. seeks a Director of Quality Assurance (Finance) to provide strategic and operational leadership for QA across infectious disease programs.

You will design and implement global quality systems, ensure FDA/ICH/GxP compliance, and collaborate with executives, regulators, CMOs, and external consultants to enable regulatory approvals. You will oversee internal teams and external vendors, drive continuous improvement, and support submissions and inspections while ensuring product

Qualifications

• Experience with global quality systems across R&D to launch.
• Strong regulatory knowledge and compliance experience.
• Proven ability to lead, train, and manage teams and external vendors.

Responsibilities

• Oversee global quality systems in collaboration with CEO and partners.
• Develop budgets and QA plans shaping QA strategy across programs.
• Lead quality assurance for development, manufacturing, testing and release.
• Support regulatory submissions and inspections.

Skills

Quality systems

Regulatory knowledge

GxP compliance

Leadership

Audits & vendor oversight

Education

Biology/Life Sciences degree

Job description

Qpex Biopharma Inc. seeks a Director of Quality Assurance (Finance) to provide strategic and operational leadership for QA across infectious disease programs.

You will design and implement global quality systems, ensure FDA/ICH/GxP compliance, and collaborate with executives, regulators, CMOs, and external consultants to enable regulatory approvals. You will oversee internal teams and external vendors, drive continuous improvement, and support submissions and inspections while ensuring product