QA Compliance & Regulatory Affairs Manager

About the role

Truvant Health and Beauty is a trusted partner to leading companies in the healthcare industry. We provide clients with labeling and packaging options as well as comprehensive supply chain solutions. The QA Compliance & Regulatory Affairs Manager is responsible for managing and maintaining the company's Quality Management System (QMS) and ensuring compliance with applicable FDA regulations, cGMP requirements, customer standards, and third-party certification programs.

Responsibilities

• Update and revise SOPs, and effectively monitor and enforce compliance with the company’s SOPs and cGMPs
• Support compliance functions such as inspection readiness/remediation activities, generation of Key Indicators for performance and compliance monitoring, and continuous improvements
• Support and maintain quality system programs including Deviation, CAPA, and Change Control processes
• Conduct internal and customer investigations, including root cause analysis and documentation of findings
• Oversee the CAPA system with emphasis on timely completion, effectiveness, and closure of actions
• Evaluate new client and product opportunities to determine applicable regulatory, registration, certification, and licensing requirements
• Submit new and revised printed materials to certifying agencies as required
• Identify potential compliance risks proactively and escalate issues to management with recommended corrective actions
• Communicate with all other departments and must be able to exchange accurate information in these circumstances
• Manage registration, renewal, and maintenance of all site certifications
• Plan, coordinate, and perform internal audits to ensure ongoing compliance with regulatory and internal standards
• Manage and oversee Food Safety, Food Defense, HACCP/HARPC, and FDA compliance programs to ensure ongoing regulatory compliance and audit readiness
• Oversee QA Systems activities to ensure effective management of quality documentation, records, compliance tracking, and quality system processes
• Oversee QA Training activities to ensure effective implementation, documentation, and compliance of employee training programs
• Plan, coordinate, and conduct supplier and vendor audits to assess compliance with applicable quality, regulatory, and customer requirements
• Support Supplier Qualification and Risk Assessment programs
• Actively participate in continuous improvement initiatives to enhance quality, compliance, and operational efficiency
• Prepare and report Quality and Compliance KPIs on a monthly basis
• Assist with equipment and process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Assist with Environmental Monitoring programs, cleaning validations/verifications, and pathogen monitoring activities
• Provide Quality support for new client onboarding, product launches, new SKU implementation, and special projects
• Support cross-functional teams in the execution of quality, regulatory, and compliance initiatives
• Support the development, coordination, delivery, and documentation of employee training programs, including cGMP, Food Safety, Food Defense, HACCP/HARPC, and other quality and compliance-related training

Requirements

• Minimum of 5 years of experience in the Nutritional Supplement, Vitamin, and/or Over-the-Counter (OTC) Drug industry
• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Food Science, Microbiology, or related field) strongly preferred
• Applied knowledge of FDA cGMP regulations (21 CFR Parts 210, 211, 111, and 117), with hands-on experience supporting quality systems, deviations, CAPAs, audits, and regulatory compliance in a GMP-regulated environment
• PCQI and/or HACCP certification preferred
• Excellent verbal, written, and interpersonal communication skills
• Advanced proficiency in Microsoft Excel and other Microsoft Office applications
• Strong attention to detail, organizational skills, and ability to effectively manage multiple priorities
• Demonstrated administrative and organizational skills with the ability to work efficiently in a fast-paced, dynamic environment
• Self-motivated with the ability to work independently while maintaining a collaborative, team-oriented approach
• Demonstrated commitment to professional growth, continuous learning, and taking on new responsibilities as business needs evolve
• Experience supporting FDA, customer, third-party certification, and regulatory audits preferred
• Experience with quality systems including CAPA, Change Control, Deviations, Internal Audits, Supplier Qualification, and Document Control preferred