About the Company

VIZOR is a material coating technology company with offices in NYC and NJ. The company has created a suite of active ingredients and specialty raw materials that go into various consumer goods. The team is comprised of some of the leading technical minds in personal care with over 50 years of combined experience in the industry.

We are seeking an experienced Regulatory and Compliance Specialist to lead our quality management and regulatory compliance efforts in our OTC and personal care manufacturing operations. Personal Care experience is required for this opportunity. This critical role is responsible for ensuring all products meet or exceed industry standards and regulatory requirements, while continuously enhancing our quality processes to drive excellence across the organization.

Key Responsibilities

• Quality Management System (QMS) Development: Design and implement a comprehensive QMS that integrates quality assurance, quality control, and compliance processes throughout the company.
• Regulatory Compliance: Ensure adherence to FDA, EPA, ISO, and other relevant national and international standards, with particular focus on solid oral dosage forms and personal care products.
• Raw Material Qualification and Documentation: Oversee the qualification and validation processes for raw materials, ensuring they meet regulatory and quality standards. Manage and maintain documentation for Certificates of Analysis (CoAs), vendor qualifications, and material specifications to guarantee consistency, traceability, and compliance.
• Audit Management: Oversee internal and external audits, facilitating corrective actions, and ensuring effective resolution of any findings. Lead internal audits to maintain compliance with FDA and other regulatory standards.
• Inspection Readiness: Prepare for FDA and international health authority inspections, managing all stages from initiation to closure. Assist in preparation for PAI audits for new product approvals, compiling documents, and ensuring site readiness.
• Cross-Functional Leadership: Work closely with R&D, production, and supply chain teams to integrate quality and compliance into product development and manufacturing.
• Stakeholder Communication: Serve as the primary contact for regulatory bodies, industry associations, and key customer quality representatives. Address any quality or compliance issues swiftly, including customer complaints and product recalls, and provide transparent communication.
• Policy Development and Continuous Improvement: Foster a culture of continuous improvement, implement best practices, and stay current with industry advancements in quality assurance technologies.

Qualifications

• Annual bonus (up to 10% of salary)
• Bachelor's degree with 7+ years of experience in Quality/Regulatory Compliance in the personal care industry; advanced degree preferred.
• In-depth understanding of FDA, cGMP regulations, and industry standards relevant to OTC manufacturing and personal care products.
• Demonstrated experience leading quality and compliance teams, particularly in manufacturing environments, with expertise in regulatory inspections, internal audits, and risk mitigation.
• Strong knowledge of supplier quality management and a proactive approach to maintaining compliance in a fast-paced, regulatory-focused industry.

Skills and Competencies

• Detail-oriented with a rigorous approach to quality assurance and regulatory compliance.
• Excellent interpersonal and leadership skills with experience managing cross-functional teams.
• Ability to foster a quality-driven culture and continuous improvement mindset.
• Strong communication and problem-solving skills, with the ability to handle complex regulatory issues effectively

Compensation:

• Annual bonus (up to 10% of salary)
• 401 K
• Annual raises based on performance
• 9 to 5 shift with Early Fridays
• Company paid holiday between Christmas and New Year
• Medical and Dental coverage
• Paid Gym Membership
• Company paid Health Savings Account (HSA) of $2,600/year

Equal Opportunity Employer:

We believe that becoming an increasingly diverse, equitable, and inclusive workplace makes us a more successful, relevant, competitive, and resilient organization. As such, Next Step Laboratories is an equal opportunity employer that prohibits discrimination and harassment of any kind.