Quality Systems Leader — GMP & Compliance

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Director of Quality Systems to lead QA and quality systems for clinical and commercial operations in California. You will advance the QMS, drive inspection readiness, and ensure scalable, compliant processes across late-stage development and commercial launch.

The role requires hands-on QA expertise and collaborative leadership to build a proactive quality culture. You will mentor the QS team, partner with Regulatory Affairs on CMC submissions, and drive

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 10+ years in Quality Assurance with at least 5 years in leadership within a regulated industry.

Responsibilities

• Lead and manage the QS team to align with company objectives and regulatory standards.
• Develop and maintain QMS to ensure GMP, FDA, ICH compliance and lifecycle readiness.
• Design and optimize the QMS including eQMS integration (Veeva) and document control processes.
• Oversee SOPs, batch records, specifications, testing, and GMP-CMC documents.
• Manage document lifecycle, version control, approvals, and archiving per regs.
• Establish quality metrics dashboards and KPIs for system effectiveness.
• Drive QA policies across all departments and audit readiness programs.
• Support regulatory inspections and timely resolution of CAPA and deviations.
• Collaborate with R&D, manufacturing, regulatory, and supply chain for product quality.

Skills

QA leadership

GMP knowledge

FDA regulations

QMS design & maintenance

Quality risk management

Cross-functional collaboration

Audits & inspections

Document control

Change control

Leadership & mentoring

Education

Bachelor's degree in Life Sciences or related

Tools

Veeva

Job description

Viking Therapeutics, Inc. is seeking a Director of Quality Systems to lead QA and quality systems for clinical and commercial operations in California. You will advance the QMS, drive inspection readiness, and ensure scalable, compliant processes across late-stage development and commercial launch.

The role requires hands-on QA expertise and collaborative leadership to build a proactive quality culture. You will mentor the QS team, partner with Regulatory Affairs on CMC submissions, and drive