GxP QMS Lead — Compliance & Process Optimization

Viking Therapeutics; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Quality Management Systems Manager to drive continuous improvement of GxP quality systems on the Veeva Basic platform.

You will work cross-functionally to ensure regulatory compliance and rating of activities across development, manufacturing, testing, release, and distribution of pharma and device products. The role requires leadership in prioritizing and delivering quality system initiatives, coordinating audits, CAPAs, and document control while

Qualifications

• Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
• Minimum of eight (8) years of experience in the regulated pharmaceutical and/or biotechnology industry, with at least five (5) years in a leadership role.
• Hands-on, expert level experience with full Veeva Vault or Veeva Basics implementations, ideally within the Vault Quality Suite.
• Veeva Vault Administrator or Vault Quality certification is a plus.

Responsibilities

• Identify, champion, and drive cross-functional improvement initiatives to enhance quality systems and processes.
• Facilitate stakeholder engagement to monitor and improve quality systems.
• Plan, coordinate, and lead internal audit activities including observations follow-up.
• Coordinate partner response development and oversee CAPAs and investigations.
• Develop, review, and approve controlled documents in line with regulatory requirements and company standards.
• Support development of registers, KPIs, metrics, and dashboards for routine reporting.

Skills

Project management

Leadership

GxP knowledge

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in life sciences

Tools

Veeva Vault

Job description

Viking Therapeutics, Inc. is seeking a Quality Management Systems Manager to drive continuous improvement of GxP quality systems on the Veeva Basic platform.

You will work cross-functionally to ensure regulatory compliance and rating of activities across development, manufacturing, testing, release, and distribution of pharma and device products. The role requires leadership in prioritizing and delivering quality system initiatives, coordinating audits, CAPAs, and document control while