QA Compliance & Regulatory Affairs Manager
hace 3 días
Caldwell
Job DescriptionDescription: 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. This position provides leadership and oversight of quality system activities, including deviations, CAPAs, change controls, internal audits, document control, training, supplier qualification, inspection readiness, and continuous improvement initiatives. The QA Compliance & Regulatory Affairs Manager is responsible for overseeing the QA Systems and QA Training functions to ensure quality processes, documentation practices, training programs, and compliance records are effectively maintained. This role manages Food Safety, Food Defense, HACCP/HARPC, and regulatory compliance programs while supporting new client onboarding, product launches, certification renewals, and customer and regulatory audits. Requirements: RESPONSIBILITIES: Essential Functions: • 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. SOPs, specifications, and cGMP requirements., • 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. Nonessential Functions/Demands: · Support Supplier Qualification and Risk Assessment programs. · Perform other related duties as assigned. · 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. QUALIFICATION 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.
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