Quality Systems Lead

About Niagen Bioscience

Niagen Bioscience (NASDAQ:NAGE), formerly ChromaDex, Corp., is a leading global bioscience company focused on unlocking the potential of NAD+ with cutting-edge precision science. With over 25 years dedicated to research and innovation, the company develops solutions to promote better aging. Their prominent ingredient, Niagen®, is supported by more than 35 peer-reviewed clinical studies and over 300 international research partnerships. The key products include Tru Niagen®, a daily supplement that elevates NAD+ levels, and Niagen® Plus, which offers pharmaceutical-grade intravenous and injectable treatments. Operating from facilities in California and Colorado, Niagen Bioscience is a pioneer in NAD+ technology and a major player in the expanding healthy-aging sector.

Company Culture - Our C.H.E.

The team embodies the C.H.E. philosophy, emphasizing Character (a positive mindset, commitment, and integrity), Horsepower (good judgment, innovative problem-solving, and a strong work drive), and Experience (functional expertise and skillfulness). Employees thrive in a cooperative atmosphere, adapting swiftly to dynamic circumstances.

Role Summary

The Quality Systems Lead will play a critical role in supporting Quality Assurance activities by designing, managing, and improving processes to ensure compliance with internal and regulatory standards. This position is based onsite at the Longmont, Colorado laboratory.

Key Responsibilities

• Design and manage forms, workflows, applications, and data dashboards within the Cloudtheapp Quality Management System (QMS).
• Oversee employee accounts within the QMS in collaboration with QA management.
• Lead regular meetings with the QMS developer to address system upgrades, modifications, and troubleshooting.
• Conduct employee training on QMS functionalities and monitor training completion rates.
• Deliver annual Good Manufacturing Practices (GMP) training sessions.
• Administer document control processes, including authoring, reviewing, and updating Standard Operating Procedures (SOPs).
• Chair weekly Change Management meetings to initiate and oversee modifications within the QMS.
• Create and revise master specifications, labels, and related quality records.
• Lead and coordinate the Internal Audit program.
• Support the semi-annual Management Review assessing company quality performance.
• Review and approve Certificates of Analysis and internal analytical reports.
• Examine batch records from contract manufacturers ensuring accuracy and completeness.
• Assist in customer feedback investigations by liaising with relevant departments to resolve issues.
• Draft and critically review deviations, Corrective and Preventive Actions (CAPAs), and other quality documentation.

Qualifications and Skills

• Bachelor's degree in scientific or engineering disciplines, particularly related to dietary supplements, food manufacturing, or pharmaceuticals preferred.
• Minimum two years of experience in Quality Assurance.
• Familiarity with electronic Quality Management Systems and change control processes.
• Internal Audit training is highly desirable; Six Sigma certification is advantageous.
• Proficient in Microsoft Word and web-based quality management software.
• Excellent verbal and written communication capabilities, able to engage effectively in meetings and digital communications.
• Demonstrates leadership presence with confidence in group discussions.
• Driven to complete quality tasks and maintain documentation with meticulous attention to detail.
• Adaptable to shifting priorities with a willingness to embrace diverse responsibilities.

Additional Information

Niagen Bioscience offers a competitive salary, accessible health benefits, company-sponsored life insurance, wellness programs, retirement plans with matching contributions, paid holidays and time off, career advancement possibilities, and a flexible work environment.

Note: The recruitment process may incorporate artificial intelligence tools to enhance application and screening efficiency; however, all final decisions rest with human evaluators.