Director, Quality Assurance

Summary

Join Nutrafol as the Director of Quality Assurance and lead the Quality Assurance Department, bringing your expertise in dietary supplements and cosmetics to a growing company. You will manage and improve QA programs, ensuring compliance with FDA regulations. This role requires strong leadership, collaboration, and communication skills to guide the team and stakeholders. You will champion continuous improvement, prepare for regulatory inspections, and collaborate across departments. The position offers a competitive salary and a comprehensive benefits package, including remote work flexibility.

Requirements

• Bachelor’s degree in quality assurance, science, medical sciences, pharmacology, etc., or an equivalent combination of education and experience
• 10+ years of US dietary supplement QA experience or combination of US dietary supplement, cosmetic, foods, OTC experience
• 5+ years of experience hiring, leading, and mentoring a team
• In-depth knowledge and experience on FDA and applicable laws and regulations, as well as of cGMP standards 21 CFR 111 and 117
• Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skills
• Strong verbal and written communication skills (including analysis, interpretation, & reasoning)
• Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external stakeholders
• Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment
• Self-motivated with critical attention to detail, deadlines, and reporting
• Excellent written and verbal communication skills

Responsibilities

• Manage and continuously improve Quality Assurance programs and procedures in accordance with FDA Dietary Supplement and Cosmetic regulations. Programs include but are not limited to: Product Release, Document Management, Specifications, Change Control, Supplier Qualification, Deviation/Non-Conformance, CAPA, Training, Product Quality Complaints, Adverse Events, Stability
• Continuously improve, develop, write and implement Quality Assurance standard operating procedures (SOPs) ensuring compliance with the company's policies and FDA regulations
• Work within Veeva QualityOne to support various Quality processes including but not limited to document management, non-conformances, CAPAs, and product quality complaints
• Champion continuous improvements to our Quality Systems, implementing value-added standards and procedures to protect the brand while driving growth ambition
• Ensure the company is prepared for regulatory inspections and perform mock recalls
• Review and approve specifications such as testing, packaging, artwork, formula specifications
• Define and monitor metrics to track compliance and process effectiveness
• Participate as an effective member of cross-functional teams including Formulation, Product Development, Supply Chain and Operations to ensure timely and compliant deliveries
• Work with internal and external companies to ensure an appropriate quality framework is in place to ensure end-to-end quality compliance for the business
• Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, influencing, motivating, and consensus and team building
• Provide coaching, mentoring, and training within the Quality Assurance team
• Maintains an open channel for communication between various stakeholders
• Maintain specialized product category knowledge
• Perform management tasks for the team. These duties include conducting reviews, maintaining team motivation and dividing the workload among members of the team
• Execute robust end-to-end quality strategy, from product development to commercialization and on-going

Preferred Qualifications

ASQ Certification and PCQI

Benefits

• Fully remote work experience
• Comprehensive medical, dental, and vision package, including FSA program
• 401K with employer match
• Quarterly Bonus Program
• Flexible PTO
• Two company-wide wellness breaks every day
• Free lunch on us every Tuesday and Thursday via Seamless/Grubhub
• Monthly wellness stipend
• Monthly internet stipend
• Monthly cell phone stipend
• Annual learning & development stipend
• Wellness Program, including virtual Wellness Sessions & No-Meeting Wednesdays
• Free meditation app membership (Headspace)
• Free Nutrafol subscription
• Pet insurance and benefit programs