QMS Lead - GxP & Veeva Vault Expert

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 120,000 - 140,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Quality Management Systems Manager to drive continuous improvement of the GxP QMS on the Veeva Basic platform, ensuring compliance with FDA, ICH, and ISO standards across development, manufacturing, testing, release, and distribution of products.

The role collaborates with cross-functional teams to lead audits, CAPAs, change controls, and metric dashboards, applying project management methods to prioritize initiatives.

Qualifications

• Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
• 8+ years in regulated pharmaceutical/biotech, with 5+ in leadership.
• Hands-on Veeva Vault or Veeva Basics implementations experience.
• Veeva Vault certification is a plus.

Responsibilities

• Identify and drive cross-functional quality system improvements.
• Lead change control boards and material reviews.
• Coordinate internal audits and CAPA programs.
• Develop and review controlled documents per regulations.
• Monitor and report quality metrics and KPIs.
• Maintain awareness of evolving regulatory guidance.

Skills

GxP compliance

Project management

Cross-functional leadership

Quality systems

Regulated environment

Communication skills

Continuous improvement

Education

Bachelor's degree in life sciences or related field

8+ years in regulated pharma/biotech

Veeva Vault Administrator / Vault Quality cert (a plus)

Tools

Veeva Vault

EMDS / EQMS

Job description

Viking Therapeutics, Inc. is seeking a Quality Management Systems Manager to drive continuous improvement of the GxP QMS on the Veeva Basic platform, ensuring compliance with FDA, ICH, and ISO standards across development, manufacturing, testing, release, and distribution of products.

The role collaborates with cross-functional teams to lead audits, CAPAs, change controls, and metric dashboards, applying project management methods to prioritize initiatives.