Global Director of Quality Assurance & Compliance

Qpex Biopharma, Inc.; San Diego (CA); Vor Ort; USD 200.000 - 240.000; Vollzeit

Zusammenfassung

Qpex Biopharma, Inc. in San Diego seeks a Director of Quality to provide strategic and operational leadership for QA across multi-therapeutic infectious disease programs, ensuring compliance with FDA, ICH, GLP, GCP and GMP.

You will design global quality systems, oversee development, manufacturing and release activities, manage internal teams and external vendors, and support regulatory submissions and inspections to enable approvals and commercialization.

Qualifikationen

• BS or advanced degree in Biology or Life Sciences with 10+ years in pharma/biotech.
• Global quality systems experience from R&D to launch.
• Proven track record building and executing quality systems.
• Regulatory knowledge and interactions with authorities.
• Experience supervising personnel and projects; strong GCP/ICH/GMP knowledge.

Aufgaben

• Oversee quality systems in consultation with CEO, Shionogi Quality Groups, Qpex CMO, Clinical Operations, GMP staff and external consultants.
• Develop QA plans and initiate quality systems across disciplines.
• Establish QA programs matched with regulatory requirements for development.
• Assist in writing/assembling CMC sections of regulatory submissions (IND, CTA, IMPDs).
• Coordinate internal/external audits and oversee vendor compliance.

Kenntnisse

Quality systems

Regulatory knowledge

Leadership

GCP/ICH/GMP knowledge

CMC management

Ausbildung

BS or advanced degree in Biology or Life Sciences

Jobbeschreibung

Qpex Biopharma, Inc. in San Diego seeks a Director of Quality to provide strategic and operational leadership for QA across multi-therapeutic infectious disease programs, ensuring compliance with FDA, ICH, GLP, GCP and GMP.

You will design global quality systems, oversee development, manufacturing and release activities, manage internal teams and external vendors, and support regulatory submissions and inspections to enable approvals and commercialization.