Senior Director, Clinical Quality & Compliance

Viking Therapeutics, Inc.; San Diego (CA); Presencial; USD 195.000 - 215.000; Jornada completa

Descripción de la vacante

Viking Therapeutics, Inc. is seeking a Director, Clinical Quality Assurance to lead the Clinical QA function across early- through late-stage development.

You will establish phase-appropriate, risk-based GCP quality systems, ensure sponsor oversight, and drive inspection readiness, CAPA management, and continuous improvement to support NDA/BIMO readiness. The role partners with Clinical Development, Regulatory Affairs, Pharmacovigilance, and CROs to safeguard data integrity and participant

Formación

• Bachelor's or Master's degree in Life Sciences or related discipline.
• 12+ years of progressive Clinical Quality Assurance experience in pharma/biotech.
• Leadership experience in cross-functional quality initiatives and/or Clinical QA teams.
• Experience supporting sponsor GCP inspection readiness and FDA BIMO inspections.
• Expert knowledge of GCP regulations (21 CFR Parts 11, 50, 54, 56, 312) and ICH guidelines.

Responsabilidades

• Lead the Clinical QA function and develop a QA strategy aligned with programs.
• Ensure QA activities comply with global GCP standards and SOPs.
• Provide independent QA input throughout development lifecycles.
• Develop and improve phase-appropriate QA systems and governance.
• Oversee CRO/vendor quality oversight and CAPA processes.
• Lead GCP inspection readiness, mock inspections, and responses.
• Develop quality metrics, trends, and internal reporting.
• Mentor and scale Clinical QA personnel for portfolio support.

Conocimientos

Leadership

GCP knowledge

Quality risk management

Vendor oversight

FDA inspections

Quality systems

Cross-functional collaboration

Data integrity

Audit strategy

Educación

Bachelor's or Master's in Life Sciences

Herramientas

eQMS (Veeva Quality/Veeva Vault)

Descripción del empleo

Viking Therapeutics, Inc. is seeking a Director, Clinical Quality Assurance to lead the Clinical QA function across early- through late-stage development.

You will establish phase-appropriate, risk-based GCP quality systems, ensure sponsor oversight, and drive inspection readiness, CAPA management, and continuous improvement to support NDA/BIMO readiness. The role partners with Clinical Development, Regulatory Affairs, Pharmacovigilance, and CROs to safeguard data integrity and participant