Global QA Director, Drug Development

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

Job summary

Qpex Biopharma, Inc. seeks a Director of Quality to lead QA across multi-therapeutic infectious disease programs in a global setting.

The role shapes global quality systems to meet FDA, ICH, GLP, GCP and GMP standards, coordinating with executive teams, regulatory affairs, and external partners. The position requires a BS or higher in Biology or Life Sciences with 10+ years in pharma/biotech QA, strong regulatory knowledge, and a proven track record in compliance, inspections, and product

Qualifications

• BS or advanced degree in Biology or Life Sciences.
• At least 10 years of experience in pharma/biotech R&D, QA or related areas.
• Experience with global quality systems and regulatory interactions.

Responsibilities

• Direct multi-therapeutic, multi-national QA oversight in Phase 1–3 programs.
• Oversee quality systems in consultation with senior leadership and CROs.
• Assist in regulatory submissions (IND/CTA/IMPD) and inspections.
• Develop QA plans and training programs for staff and vendors.
• Lead internal and external teams to ensure compliance and product quality.

Skills

Regulatory knowledge

Quality systems

GCP/ICH/GMP knowledge

Quality Assurance leadership

Education

BS or advanced degree in Biology or Life Sciences

Job description

Qpex Biopharma, Inc. seeks a Director of Quality to lead QA across multi-therapeutic infectious disease programs in a global setting.

The role shapes global quality systems to meet FDA, ICH, GLP, GCP and GMP standards, coordinating with executive teams, regulatory affairs, and external partners. The position requires a BS or higher in Biology or Life Sciences with 10+ years in pharma/biotech QA, strong regulatory knowledge, and a proven track record in compliance, inspections, and product