Director, Quality Systems

Director Quality Systems

The Director Quality Systems will lead and support quality assurance and quality systems activities for Viking's clinical and commercial-stage operations. The role advances the company's Quality Management System, drives inspection readiness, and ensures quality processes are scalable, compliant, and aligned with late-stage development and commercial launch. The ideal candidate brings hands-on QA and Quality Systems experience, deep knowledge of GMP and FDA requirements, and a proven ability to partner cross-functionally to build a proactive, risk-based quality culture.

The main responsibilities of this role include:

• 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 relevant 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 the entire quality systems infrastructure, including Standard Operating Procedures (SOPs), Policies, batch records, specifications, testing, validation protocols and other GMP CMC documents.
• Manage document lifecycle management ensuring version control, approval workflows, and archival in compliance with regulatory requirements
• Establish and maintain quality metrics dashboards and Key Performance Indicators (KPIs) for system effectiveness
• Establish and enforce quality assurance policies and procedures across all operational departments
• Support the preparation and execution of internal audits, including regulatory inspections, to ensure compliance with regulatory requirements
• Ensure timely resolution of quality-related issues, including non-conformances, deviations, and CAPA (Corrective and Preventive Actions)
• Maintain inspection readiness and serve as primary QA point of contact for regulatory inspections
• Collaborate with cross-functional teams (R&D, manufacturing, regulatory affairs, supply chain, etc.) to ensure product quality throughout the entire lifecycle
• Partner with Regulatory Affairs to support CMC sections of regulatory submissions (IND, BLA, NDA)
• Support technology transfer activities and new product introductions from a quality systems perspective
• Lead continuous improvement initiatives leveraging methodologies to enhance product quality, manufacturing processes, and operational efficiency
• Provide leadership in Quality Risk Management (QRM), including identification, assessment, and mitigation of quality risks using ICH Q9 principles
• Prepare and present quality performance metrics, trending analysis, and reports to senior management and board of directors
• Mentor and develop QS staff, fostering a culture of accountability, compliance, and continuous professional growth
• Other duties as assigned.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field
• 10+ years of progressive experience in Quality Assurance with at least 5 years in a leadership role within a regulated industry (pharmaceutical, biotechnology, or medical devices)

Knowledge and Skills

• Strong knowledge of regulatory requirements, including FDA, GMP, ICH guidelines, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, and 1271
• Demonstrated expertise in Quality Management Systems (QMS) design, implementation, and maintenance
• Proven experience with electronic quality systems (eQMS) platforms such as Veeva
• Knowledge of Quality Risk Management methodologies (ICH Q9, FMEA, etc.)
• Demonstrated ability to drive process improvements and manage complex quality systems in dynamic environments
• Experience managing regulatory inspections and audit readiness programs
• Excellent problem-solving, analytical, and decision-making skills
• Strong written and verbal communication skills, with the ability to interact with senior leadership, regulatory agencies, and external stakeholders
• Experience in preparing and presenting reports and metrics to senior management and board members
• Strong leadership and interpersonal skills, with the ability to mentor and guide teams towards excellence
• Ability to work effectively in a fast-paced, entrepreneurial environment with changing priorities

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.

Salary Description

$170,000.00 - $210,000.00 annual salary