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: $130-160k
Schedule: Full-Time Hybrid/remote
 

Overview
Our 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 regulations.

Responsibilities
Quality Management System

• Oversee the revision, preparation, and dissemination of new and updated compliance standards and procedures
  

• Coordinate, supervise, and support compliance-related programs, including compliance training, testing and reporting, disaster recovery, contingency planning, and records warehousing and destruction
  

• Write and review audit documentation, SOPs, and work instructions
  

• Provide oversight of Specification Management, Document Control & Record Keeping, Product Inspection and Release, Analytical Testing, and Product Certifications

Vendor Compliance

• Monitor supplier performance and complete trending of Supplier Non-Conformance Reports, including development and implementation of Corrective and Preventive Actions (CAPAs)
  

• Facilitate Material Review Board meetings to provide dispositions for the release or rework of out-of-specification materials
  

• Conduct periodic audits of Contract Manufacturers, Raw Material Suppliers, 3rd Party Logistics providers, and Contract Laboratories

New Product Development

• Support 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 regulations

Consumer Complaint Management

• Coordinate with Customer Service, Supply Chain, and co-manufacturers to drive consumer complaint reduction initiatives related to Adverse Events and Product Defects
  

• Identify complaint trends requiring root cause analysis and work with suppliers and co-manufacturers to develop and implement corrective and preventive actions

Supply Chain and Sales Support

• Support Sales with the registration and marketing of client products in foreign markets
  

• Manage product certification and registration
  

• Coordinate with Sales to define and incorporate customer requirements into specifications and business processes
  

• Coordinate with Sales, Supply Chain, and Finance to ensure 3PL order fulfillment procedures meet customer requirements
  

• Back up and support the Regulatory and Quality Manager, as needed

Qualifications

• Bachelor’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 accountabilities
  

• 5+ years of progressive Quality or Product Development experience in a cGMP or regulated manufacturing industry
  

• Strong 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 regulations
  

• Technical writing experience in a compliance or scientific environment (e.g., microbiology, food science, chemistry, or biochemistry) preferred
  

• Advanced Excel and Google Suite capabilities preferred
  

• Experience working in a start-up environment is a plus

What Happens Next
Once 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 limitless.

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