Sr. Manager of Quality

Sr. Manager of Quality

Kelly® Science & Clinical is seeking a Sr. Manager of Quality Control and Assurance for a direct-hire position at a cutting-edge client in the dietary supplement industry in Denver, CO. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts

.
Salary: $130-16

0kSchedule: Full-Time Hybrid/remo

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Overv

iewOur client is an industry-leading company that's leading the way in gut health supplements. We are looking for a driven and detail-oriented Sr. Manager of Quality Control and Assurance to join this growing team. This role is critical in ensuring the integrity, safety, and compliance of dietary supplement products. The ideal candidate will work closely with internal and external stakeholders — including marketing, quality, 3rd party suppliers, raw material suppliers, and regulatory agencies — to support new product development, supply chain, and sales in commercializing products that are safe, efficacious, high quality, and compliant with all applicable regulatio

ns.
Responsibili

tiesQuality Management Sy

• stemOversee the revision, preparation, and dissemination of new and updated compliance standards and proced
• uresCoordinate, supervise, and support compliance-related programs, including compliance training, testing and reporting, disaster recovery, contingency planning, and records warehousing and destruc
• tionWrite and review audit documentation, SOPs, and work instruct
• ionsProvide oversight of Specification Management, Document Control & Record Keeping, Product Inspection and Release, Analytical Testing, and Product Certificat

ionsVendor Compli

• anceMonitor supplier performance and complete trending of Supplier Non-Conformance Reports, including development and implementation of Corrective and Preventive Actions (CA
• PAs)Facilitate Material Review Board meetings to provide dispositions for the release or rework of out-of-specification mater
• ialsConduct periodic audits of Contract Manufacturers, Raw Material Suppliers, 3rd Party Logistics providers, and Contract Laborato

riesNew Product Develop

• mentSupport New Product Development, Brand, Creative, and Marketing teams during the design and approval of new product packaging, product listings, and marketing materials to ensure compliance with applicable regulat

ionsConsumer Complaint Manage

• mentCoordinate with Customer Service, Supply Chain, and co-manufacturers to drive consumer complaint reduction initiatives related to Adverse Events and Product Def
• ectsIdentify complaint trends requiring root cause analysis and work with suppliers and co-manufacturers to develop and implement corrective and preventive act

ionsSupply Chain and Sales Sup

• portSupport Sales with the registration and marketing of client products in foreign mar
• ketsManage product certification and registra
• tionCoordinate with Sales to define and incorporate customer requirements into specifications and business proce
• ssesCoordinate with Sales, Supply Chain, and Finance to ensure 3PL order fulfillment procedures meet customer requirem
• entsBack up and support the Regulatory and Quality Manager, as ne

eded
Qualifica

• tionsBachelor's degree in Science, Chemistry, Biochemistry, Pharmacology, Biology, Food Science, or a related field; or an equivalent combination of 4–6 years of related experience and/or education/training sufficient to successfully perform key accountabil
• ities5 years of progressive Quality or Product Development experience in a cGMP or regulated manufacturing ind
• ustryStrong working knowledge of FDA regulations, GMP standards, Code of Federal Regulations Title 21 Parts 100–199, DSHEA/NLEA Labeling Regulations (21 CFR Part 101), and FALCPA regula
• tionsTechnical writing experience in a compliance or scientific environment (e.g., microbiology, food science, chemistry, or biochemistry) pref
• erredAdvanced Excel and Google Suite capabilities pref
• erredExperience working in a start-up environment is a

plus
What Happen

s NextOnce you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limi