Quality Assurance Manager

Reports To: Director of Quality Assurance Employment Type: Full-Time| On-Site Job Summary: The Quality Manager is responsible for leading and developing the Quality team while ensuring full compliance with 21 CFR Part 111 and all applicable regulatory, customer, and internal quality standards. This role oversees quality systems, documentation control, investigations, supplier qualification, audit management, and customer quality support to ensure product safety, compliance, and continuous improvement. Key Responsibilities: Manage and develop the Quality team through daily oversight, performance management, coaching, and ongoing GMP and SOP training. Ensure compliance with 21 CFR Part 111 through implementation, monitoring, and execution of Standard Operating Procedures (SOPs) across the facility. Lead regulatory and third-party audits, including audit preparation, hosting, coordination, and timely response to audit findings. Manage employee training compliance, including onboarding, GMP training, SOP training, qualification programs, and maintenance of training records. Own and maintain Master Manufacturing Records (MMRs), Batch Production Records (BPRs), and controlled documentation systems to ensure accuracy and regulatory compliance. Own and manage deviation, nonconformance, Out-of-Specification (OOS), and CAPA investigations through root cause analysis and timely closure. assessments, performance monitoring, and ongoing supplier evaluations. Ensure product labeling, specifications, and formulations meet regulatory requirements and customer specifications prior to release. Execute and oversee change control activities impacting product quality, safety, compliance, Manage customer quality agreements, technical questionnaires, and routine quality inquiries to ensure alignment with regulatory and contractual obligations. Investigate and draft responses to customer complaints, conduct trend analysis, and implement corrective or preventive actions as needed. Ensure audit readiness at all times and maintain programs aligned with applicable Dietary Supplement cGMP standards. Support manufacturing and packaging operations to ensure adherence to quality and product safety standards. Lead internal audit programs to verify compliance with regulatory requirements, cGMPs, and internal procedures. Collect, analyze, and trend quality data to identify opportunities for continuous improvement and risk mitigation. Perform other duties as assigned by management. Qualifications: Bachelor’s degree in Food Science, Quality Management, Biology, Chemistry, or a related scientific field. 5+ years of experience in quality assurance within dietary supplement, food, or pharmaceutical manufacturing. Strong working knowledge of 21 CFR Part 111, cGMP requirements, FDA regulations, and quality systems management. and regulatory inspections. Proven leadership experience with the ability to train, mentor, and develop quality personnel. Strong analytical, organizational, and problem-solving skills. Excellent written and verbal communication skills. Proficiency in document control systems and quality management software. Additional Skills: Strong leadership and decision-making abilities. High problem-solving skills in fast-paced manufacturing environments. Ability to manage multiple priorities and meet deadlines. Analytical mindset with the ability to interpret regulations and apply them practically. Computing skills (Word, Excel, PowerPoint) to generate reports and maintain records. Equal Opportunity Employer Statement: GummyWorks is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all #J-18808-Ljbffr