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:**  $130-160k

*
* 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…