Director, Quality Systems
Viking Therapeutics, Inc.
June 30, 2026
Remote friendly (San Diego, CA)
United States
Operations
Director Quality Systems will lead and support quality assurance and quality systems activities for clinical and commercial-stage operations, advancing the Quality Management System (QMS), driving inspection readiness, and ensuring quality processes are scalable, compliant, and aligned with late-stage development and commercial launch.
Essential Duties and Responsibilities:
- Lead and manage the QS team.
- Develop, implement, and maintain quality management strategies to ensure compliance with GMP, FDA, ICH guidelines, and other regulatory bodies.
- Design, establish, and continuously improve the QMS (document control, change control, training, and electronic quality systems/eQMS in Veeva).
- Oversee quality systems infrastructure (SOPs, policies, batch records, specifications, testing, validation protocols, and GMP CMC documents).
- Manage document lifecycle management (version control, approval workflows, archival).
- Establish and maintain quality metrics dashboards and KPIs.
- Establish and enforce QA policies and procedures across operational departments.
- Support internal audits and regulatory inspections; resolve quality issues (non-conformances, deviations, CAPA).
- Maintain inspection readiness as primary QA point of contact.
- Collaborate cross-functionally (R&D, manufacturing, regulatory affairs, supply chain) across the product lifecycle.
- Partner with Regulatory Affairs on CMC sections of submissions (IND, BLA, NDA).
- Support technology transfer and new product introductions.
- Lead continuous improvement initiatives.
- Provide leadership in Quality Risk Management using ICH Q9 principles.
- Prepare and present quality performance metrics and trending reports to senior management and the board.
- Mentor and develop QS staff.
Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 10+ years progressive Quality Assurance experience; at least 5 years in a leadership role in a regulated industry (pharma, biotech, or medical devices).
Skills/Knowledge:
- FDA/GMP/ICH/ISO 13485 knowledge; 21 CFR Parts 210, 211, 600, 820, 1271.
- QMS design, implementation, and maintenance expertise.
- eQMS experience (e.g., Veeva).
- Quality Risk Management methods (ICH Q9, FMEA).
- Audit/inspection readiness experience; strong problem-solving and communication.
- Ability to work in a fast-paced environment with changing priorities.
Essential Duties and Responsibilities:
- Lead and manage the QS team.
- Develop, implement, and maintain quality management strategies to ensure compliance with GMP, FDA, ICH guidelines, and other regulatory bodies.
- Design, establish, and continuously improve the QMS (document control, change control, training, and electronic quality systems/eQMS in Veeva).
- Oversee quality systems infrastructure (SOPs, policies, batch records, specifications, testing, validation protocols, and GMP CMC documents).
- Manage document lifecycle management (version control, approval workflows, archival).
- Establish and maintain quality metrics dashboards and KPIs.
- Establish and enforce QA policies and procedures across operational departments.
- Support internal audits and regulatory inspections; resolve quality issues (non-conformances, deviations, CAPA).
- Maintain inspection readiness as primary QA point of contact.
- Collaborate cross-functionally (R&D, manufacturing, regulatory affairs, supply chain) across the product lifecycle.
- Partner with Regulatory Affairs on CMC sections of submissions (IND, BLA, NDA).
- Support technology transfer and new product introductions.
- Lead continuous improvement initiatives.
- Provide leadership in Quality Risk Management using ICH Q9 principles.
- Prepare and present quality performance metrics and trending reports to senior management and the board.
- Mentor and develop QS staff.
Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 10+ years progressive Quality Assurance experience; at least 5 years in a leadership role in a regulated industry (pharma, biotech, or medical devices).
Skills/Knowledge:
- FDA/GMP/ICH/ISO 13485 knowledge; 21 CFR Parts 210, 211, 600, 820, 1271.
- QMS design, implementation, and maintenance expertise.
- eQMS experience (e.g., Veeva).
- Quality Risk Management methods (ICH Q9, FMEA).
- Audit/inspection readiness experience; strong problem-solving and communication.
- Ability to work in a fast-paced environment with changing priorities.