What is your mission? 

You will provide the best service to our partner brands by performing these tasks:

• Plan, execute, and manage manufacturing projects aligned with 21 CFR Part 111 cGMP and 21 CFR Part 117 requirements
• Ensure all project activities follow internal quality systems, SOPs, and FDA expectations
• Collect, analyze, and trend manufacturing and production data to identify deviations, bottlenecks, and improvement opportunities
• Lead continuous improvement initiatives using Lean, Kaizen, and Six Sigma methodologies
• Facilitate collaboration across manufacturing, QA, QC, validation, engineering, procurement, and supply chain teams
• Serve as the primary customer contact for quotations, project updates, cost discussions, change requests, and timelines
• Oversee change control activities, including assessment, documentation, approval, and implementation
• Support equipment and process qualification activities and ensure proper documentation of controls
• Develop, review, and maintain GMP project documentation such as plans, protocols, risk assessments, reports, and closeout summaries
• Identify and mitigate project, quality, and regulatory risks
• Facilitate project meetings and stage-gate reviews to track milestones and resolve issues
• Support internal audits, customer audits, and FDA inspections by preparing documentation, data, and technical explanations

Who are we looking for?

• Bachelor’s degree in Manufacturing, Engineering, Life Sciences, Business, or related fields
• 5+ years of experience in manufacturing, including project/program management with end-to-end ownership
• Proven experience in dietary supplement or nutraceutical manufacturing under FDA-regulated environments
• Experience leading cross-functional teams (Manufacturing, QA, QC, Engineering, Supply Chain, Vendors)
• Direct experience as a customer-facing project lead working with suppliers and contract manufacturers
• Strong knowledge of 21 CFR Part 111, 21 CFR Part 117, and GMP Quality Systems
• Skilled in change control, deviation/CAPA management, supplier qualification, manufacturing data analysis, and risk mitigation
• Process improvement experience with Lean, Kaizen, Six Sigma methodologies
• Ability to support equipment and process qualification activities and perform technical troubleshooting
• PMP certification (required)
• Lean / Kaizen / Six Sigma training or certification (required)
• Strong English communication skills (written and verbal)
• Strong cross-functional leadership, stakeholder management, problem-solving, and critical thinking ability
• Excellent organizational and time-management skills; ability to manage multiple projects in a regulated environment