Senior QMS Manager - GxP, Veeva Vault & CI

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Viking Therapeutics, Inc. seeks a Quality Management Systems Manager to drive continuous improvement of GxP quality systems on the Veeva Basic platform, ensuring regulatory compliance across development, manufacturing, testing, release and distribution of products.

The role collaborates across functions to lead audits, CAPAs, change controls, and KPI reporting, fostering a culture of quality and accountability in a fast-paced biotech environment in San Diego.

Qualifications

• Typically 8+ years in regulated pharma/biotech with leadership roles.
• Bachelor's degree in life sciences, chemistry, pharmacy, or related field.
• Hands-on experience with Veeva Vault or Veeva Basics (Vault Quality Suite).
• Vault Quality certification is a plus.

Responsibilities

• Identify and drive cross-functional improvements for 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 per regulatory guidance.
• Support quality management reviews, registers, KPIs, and dashboards for reporting.
• Apply project management methods to prioritize and deliver quality initiatives.
• Monitor evolving regulatory requirements and assess impact on quality systems.
• Foster a culture of quality, collaboration, and accountability.
• Perform additional duties as requested.

Skills

GxP knowledge

Project management

Leadership

Regulated environments

Quality systems focus

Education

Bachelor's degree in life sciences, pharmacy, chemistry, or related field

Tools

Veeva Vault

Vault Quality Suite (QualityDocs, QMS, Training)

Job description

Viking Therapeutics, Inc. seeks a Quality Management Systems Manager to drive continuous improvement of GxP quality systems on the Veeva Basic platform, ensuring regulatory compliance across development, manufacturing, testing, release and distribution of products.

The role collaborates across functions to lead audits, CAPAs, change controls, and KPI reporting, fostering a culture of quality and accountability in a fast-paced biotech environment in San Diego.