Director, Quality Systems
Viking Therapeutics, Inc.
August 25, 2026
Remote friendly (San Diego, CA)
United States
Operations
Director Quality Systems responsibilities:
- Lead and manage the QS team, ensuring alignment with company objectives and regulatory standards.
- Develop, implement, and maintain quality management strategies and systems to ensure compliance with GMP, FDA, ICH guidelines, and other regulatory bodies.
- Design, establish, and continuously improve the Quality Management System (QMS), including document control, change control, training systems, and electronic quality systems (eQMS) within Veeva.
- Oversee quality systems infrastructure: SOPs, policies, batch records, specifications, testing, validation protocols, and other GMP CMC documents.
- Manage document lifecycle management (version control, approval workflows, archival) per regulatory requirements.
- Establish quality metrics dashboards and KPIs for system effectiveness.
- Establish and enforce quality assurance policies and procedures across operational departments.
- Support internal audits and regulatory inspections for compliance.
- Ensure timely resolution of quality issues (non-conformances, deviations, CAPA).
- Maintain inspection readiness and serve as primary QA point of contact for regulatory inspections.
- Collaborate cross-functionally (R&D, manufacturing, regulatory affairs, supply chain) across the product lifecycle.
- Partner with Regulatory Affairs on CMC submissions (IND, BLA, NDA).
- Support technology transfer and new product introductions from a quality systems perspective.
- Lead continuous improvement and Quality Risk Management (ICH Q9) initiatives.
- Prepare and present quality performance metrics/trending reports to senior management and board.
- Mentor and develop QS staff.
Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 10+ years in Quality Assurance; at least 5 years in a leadership role in a regulated industry (pharma, biotech, or medical devices).
Required skills/knowledge:
- Deep knowledge of FDA, GMP, ICH, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, 1271.
- QMS design, implementation, and maintenance expertise.
- eQMS experience (e.g., Veeva).
- QRM methodologies (ICH Q9, FMEA, etc.).
- Regulatory inspection/audit readiness experience.
- Strong problem-solving/analytical/decision-making.
- Excellent written/verbal communication with senior leadership and regulators.
- Ability to work in a fast-paced, changing environment.
Salary: $170,000.00 - $210,000.00 annual salary.
- Lead and manage the QS team, ensuring alignment with company objectives and regulatory standards.
- Develop, implement, and maintain quality management strategies and systems to ensure compliance with GMP, FDA, ICH guidelines, and other regulatory bodies.
- Design, establish, and continuously improve the Quality Management System (QMS), including document control, change control, training systems, and electronic quality systems (eQMS) within Veeva.
- Oversee quality systems infrastructure: SOPs, policies, batch records, specifications, testing, validation protocols, and other GMP CMC documents.
- Manage document lifecycle management (version control, approval workflows, archival) per regulatory requirements.
- Establish quality metrics dashboards and KPIs for system effectiveness.
- Establish and enforce quality assurance policies and procedures across operational departments.
- Support internal audits and regulatory inspections for compliance.
- Ensure timely resolution of quality issues (non-conformances, deviations, CAPA).
- Maintain inspection readiness and serve as primary QA point of contact for regulatory inspections.
- Collaborate cross-functionally (R&D, manufacturing, regulatory affairs, supply chain) across the product lifecycle.
- Partner with Regulatory Affairs on CMC submissions (IND, BLA, NDA).
- Support technology transfer and new product introductions from a quality systems perspective.
- Lead continuous improvement and Quality Risk Management (ICH Q9) initiatives.
- Prepare and present quality performance metrics/trending reports to senior management and board.
- Mentor and develop QS staff.
Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 10+ years in Quality Assurance; at least 5 years in a leadership role in a regulated industry (pharma, biotech, or medical devices).
Required skills/knowledge:
- Deep knowledge of FDA, GMP, ICH, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, 1271.
- QMS design, implementation, and maintenance expertise.
- eQMS experience (e.g., Veeva).
- QRM methodologies (ICH Q9, FMEA, etc.).
- Regulatory inspection/audit readiness experience.
- Strong problem-solving/analytical/decision-making.
- Excellent written/verbal communication with senior leadership and regulators.
- Ability to work in a fast-paced, changing environment.
Salary: $170,000.00 - $210,000.00 annual salary.