GxP QMS Transformation Lead

VIKING THERAPEUTICS INC

San Diego (CA)

On-site

USD 150,000 - 190,000

Full time

6 days ago
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Job summary

Viking Therapeutics, Inc. is seeking a Quality Management Systems Manager (QMS Manager) to lead cross-functional initiatives aimed at improving GxP quality systems within the regulated environment.

The role emphasizes collaboration across development, manufacturing, testing, release, and distribution of products, with emphasis on Veeva Vault/Basic platforms. The ideal candidate will have a strong quality leadership background, hands-on experience with Veeva Vault, and the ability to drive

Qualifications

  • GxP knowledge across GMP, ICH, ISO and regulatory expectations.
  • Experience leading quality system improvements and change control boards.
  • Hands-on with electronic quality management systems (EMDS/EQMS).

Responsibilities

  • Identify and drive cross-functional improvements to quality systems and change control processes.
  • Coordinate and lead material and change control review boards.
  • Plan, coordinate, and lead internal audits and CAPA processes.
  • Develop and approve controlled documents aligning with regulatory guidance.
  • Support quality management reviews, KPIs, and routine reporting dashboards.
  • Apply project management methods to deliver quality initiatives.

Skills

Cross-functional leadership
Project management
Quality mindset
Stakeholder engagement
Effective communication

Education

Bachelor's degree in life sciences or related field

Tools

Veeva Vault
Veeva Basics

Job description

Viking Therapeutics, Inc. is seeking a Quality Management Systems Manager (QMS Manager) to lead cross-functional initiatives aimed at improving GxP quality systems within the regulated environment.

The role emphasizes collaboration across development, manufacturing, testing, release, and distribution of products, with emphasis on Veeva Vault/Basic platforms. The ideal candidate will have a strong quality leadership background, hands-on experience with Veeva Vault, and the ability to drive

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