Quality Systems Lead

Job description

**About Niagen Bioscience** Niagen Bioscience (NASDAQ:NAGE), formerly ChromaDex, Corp., is a global bioscience company uncovering the potential of NAD+ with precision science. Backed by 25 years of research and innovation, our team discovers, develops, and creates solutions to help people Age Better®. Our flagship ingredient, Niagen®, is one of the world's most extensively researched NAD+ precursors, backed by 35+ published, peer-reviewed human clinical studies and 300+ global research partnerships with leading institutions. Our brands are Tru Niagen®, a daily supplement proven to increase NAD+ levels, and Niagen® Plus, offering pharmaceutical-grade IV and injectable therapies. As pioneers in NAD+ technology, Niagen Bioscience sets the gold standard in scientific rigor. We operate from three strategic locations in California and Colorado, positioning us at the forefront of the rapidly growing healthy-aging industry. **Our C.H.E.** *(pronounced chi)* We enjoy working with like-minded people who embody “C.H.E.” and share our passion for health, wellness, discovery, and innovation. In our collaborative environment, employees quickly adapt to different situations, bringing: Character – A positive attitude, commitment to success, and strong ethics. Horsepower – Good judgment, creative problem-solving, and a strong work ethic. Experience – Functional knowledge and skills to perform efficiently. If you're eager to work with incredible people and contribute to something meaningful, join our team and help shape the future of bioscience on a global scale! **What we Offer:** A competitive salary, affordable health benefits, company sponsored life insurance, wellness initiatives, retirement savings with company match, paid time off, career growth opportunities and a flexible work environment. ### About the Role: The Quality Systems Lead is responsible for supporting Quality Assurance functions, primarily focused on establishing and maintaining processes to ensure compliance with internal and external requirements and regulations. This is an onsite position at our laboratory location in Longmont, CO. ### Core Expectations: - Manages and designs forms, workflows, applications, and analytic dashboards in the Quality Management System (QMS) Cloudtheapp. - Assists in QA management of employee accounts in the QMS - Leads routine meetings with the QMS developer to discuss system modifications, upgrades, and issues. - Trains employees on how to use the QMS while monitoring training completions - Conducts annual GMP training - Manages and monitors document control including new creation, reviews, and updates of SOPs. - Leads weekly Change Management meeting; initiating, documenting, and completing changes in the QMS - Creates new and revised master specification, label, and similar records - Leads Internal Audit program - In combination with other QA personnel: - Supports biannual Management Review for a quality assessment of the company - Reviews and approves Certificates of Analyses (CofAs) and other internal analytical testing reports - Reviews batch records received from the contract manufacturers for accuracy and completeness - Assists with customer feedback investigations, compiling information from relevant departments to solve issues. - Writes and/or reviews deviations, CAPAs, and other quality records ### Qualifications and Success Factors: - Bachelor’s degree in a scientific discipline or engineering in a dietary supplement, food manufacturing, or pharmaceutical industry preferred. - 2 or more years of relevant QA experience. - Experience with electronic Quality Management Systems and the change control process. - Internal Audit training strongly preferred - Six Sigma training is a plus ### Competencies & Skills: - Strong software skills, including Microsoft Word and web based quality management systems - Strong communication skills in-person and through messaging and video calls - Leadership courage with the ability to speak strongly in group settings - Action oriented to drive completion of quality related tasks and records - Strong attention to detail, particularly in quality documentation - Flexibility for changing priorities and the eagerness to take on varied responsibilities