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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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
