Quality System Specialist (Veeva eQMS Specialist)

Job Description

Job Description

Description:

We are seeking an experienced Veeva eQMS Specialist with deep expertise in Veeva Basics, ideally someone who has led or played a key role in full implementations across QualityDocs, QMS, Training, and other Vault Quality modules. This role will partner closely with Quality and cross-functional teams to translate business needs into scalable system design, ensuring that our Veeva ecosystem supports compliant, efficient, and future-ready quality operations. The ideal candidate is detail-oriented, organized, and passionate about driving quality excellence in a fast-paced environment.

Essentials Duties and Responsibilities

The main responsibilities of this role include:

• Lead or support different implementation phases of Veeva Basics modules and processes including Quality Docs, Quality Events, Supplier Quality, supporting SOPs and training

• Configure and optimize workflows, document types, metadata, training assignments, quality processes, and user roles

• Conduct detailed process mapping of current-state and future-state eQMS processes (e.g., Document Management, Change Control, Deviations, CAPA, Complaints, Training)

• Facilitate workshops with cross-functional stakeholders for training on new processes within Veeva

• Lead or support historical CMC documents migration in Veeva

• Identify opportunities for process improvements and automation within Veeva

• Maintain updates to Veeva releases, including impact assessments and SOP revisions

• Develop user training materials and deliver hands-on training for business end users

• Provide ongoing support, troubleshoot issues, and manage enhancement requests

• Serve as a subject matter expert (SME) for Veeva Basics within the Quality organization

• Maintain and manage controlled records, including batch/test records, logs, reports, and quality management documentation

• Assist in preparing materials for internal audits and ensuring documentation readiness for regulatory inspections

• Collaborate with senior team members to improve and implement quality management systems and training programs

• Assist in preparing reports and documentation related to deviations, corrective actions, and change controls

• Support Quality Management System (QMS) activities including investigations, complaints, CAPAs, inspections, quality metrics, and continuous improvement initiatives.

• Perform additional tasks as assigned

Requirements:

Education and Experience Requirements

• Bachelor’s Degree in a related field and/or 3-5 years related experience in a regulated industry

• Minimum of three (3) years of relevant QA experience in a GMP-regulated environment.

• Hands-on experience with full Veeva Vault or Veeva Basics implementations, ideally within the Vault Quality Suite (QualityDocs, QMS, Training)

• Veeva Vault Administrator or Vault Quality certification (a plus)

Knowledge and Skills Requirements

• Strong working knowledge of GxP, 21 CFR Part 11, Annex 11, and core quality system processes

• Experience working with global teams and regulated environments

• Experience in managing enhancements post-implementation and supporting continuous improvement

• Strong written and verbal communications skills

• Attention to detail and ability to manage multiple priorities

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Salary Description

$95,000.00 - $115,000.00 annual salary