VIKING THERAPEUTICS INC
Quality System Specialist (Veeva eQMS Specialist)
TLDR
Configure and optimize Veeva Quality modules, map eQMS processes, migrate CMC documents, and support audits, training, and continuous improvement.
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 ResponsibilitiesThe 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
Viking Therapeutics is focused on developing innovative therapies for metabolic and endocrine disorders, with a strong emphasis on their lead dual agonist program, VK2735. The company caters to patients and healthcare providers looking for advanced treatment options in this critical area of healthcare.
Specialist