Director, Clinical Quality & GCP 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 of Clinical Quality to lead the QA function across late-stage clinical development.

This role develops and implements phase-appropriate GCP quality systems, processes, and governance to support data integrity and regulatory readiness. You will partner with Clinical Development, Operations, Biostatistics, and Regulatory Affairs, directing QA oversight of CROs, sites, and laboratories while driving inspection readiness and risk-based quality

Formación

• Bachelor’s or Master’s degree in Life Sciences or related discipline.
• 12+ years of progressive Clinical Quality Assurance experience in pharma/biotech, including late-stage development.
• Experience leading cross-functional quality initiatives and QA personnel.
• Experience supporting sponsor GCP inspection readiness and FDA BIMO inspections; HA inspections a plus.

Responsabilidades

• Lead the Clinical Quality Assurance function and develop a QA strategy aligned with program objectives.
• Ensure QA activities comply with global GCP regulations and internal procedures.
• Represent Clinical QA on study teams and provide risk-based quality guidance.
• Develop and improve phase-appropriate QA systems, SOPs, and governance structures.
• Maintain risk-based oversight of CROs and GCP service providers, including vendor qualification and CAPA oversight.
• Partner withClinical Ops and study teams to implement quality risk management approaches.
• Provide QA input on study documentation and quality-critical processes.
• Oversee investigator sites, CROs, labs, and service-provider compliance and remediation of GCP issues.
• Provide investigations of significant quality issues, root-cause analysis, CAPA development, and escalation as needed.
• Assess significant GCP compliance issues for regulatory reporting; escalate appropriately.

Conocimientos

GCP regulatory knowledge

Quality risk management

CRO/vendor oversight

Inspection readiness

Leadership

Cross-functional collaboration

eQMS familiarity

Communication skills

Educación

Bachelor’s or Master’s in Life Sciences

Herramientas

Veeva Vault

Descripción del empleo

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

This role develops and implements phase-appropriate GCP quality systems, processes, and governance to support data integrity and regulatory readiness. You will partner with Clinical Development, Operations, Biostatistics, and Regulatory Affairs, directing QA oversight of CROs, sites, and laboratories while driving inspection readiness and risk-based quality