Quality Assurance Manager

Job Title: Quality Assurance ManagerDepartment: QualityReports To: Director of Quality AssuranceEmployment Type: Full-TimeJob Summary:The Quality Manager is responsible for leading and developing the Quality team while ensuringfull compliance with 21 CFR Part 111 and all applicable regulatory, customer, and internalquality 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, andexecution of Standard Operating Procedures (SOPs) across the facility.• Lead regulatory and third-party audits, including audit preparation, hosting, coordination, andtimely 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 regulatorycompliance.• Own and manage deviation, nonconformance, Out-of-Specification (OOS), and CAPAinvestigations through root cause analysis and timely closure.• Manage supplier qualification programs, including supplier approval, raw material riskassessments, performance monitoring, and ongoing supplier evaluations.• Ensure product labeling, specifications, and formulations meet regulatory requirements andcustomer specifications prior to release.• Execute and oversee change control activities impacting product quality, safety, compliance,or documentation.• Manage customer quality agreements, technical questionnaires, and routine quality inquiriesto ensure alignment with regulatory and contractual obligations.• Investigate and draft responses to customer complaints, conduct trend analysis, andimplement corrective or preventive actions as needed.• Ensure audit readiness at all times and maintain programs aligned with applicable DietarySupplement cGMP standards.• Support manufacturing and packaging operations to ensure adherence to quality and productsafety standards.• Lead internal audit programs to verify compliance with regulatory requirements, cGMPs, andinternal procedures.• Collect, analyze, and trend quality data to identify opportunities for continuous improvementand risk mitigation.• Perform other duties as assigned by management.Qualifications:• Bachelor's degree in Food Science, Quality Management, Biology, Chemistry, ora related scientific field.• 5+ years of experience in quality assurance within dietary supplement, food, orpharmaceutical manufacturing.• Strong working knowledge of 21 CFR Part 111, cGMP requirements, FDAregulations, and quality systems management.• Experience managing audits, CAPA systems, supplier qualification programs,and regulatory inspections.• Proven leadership experience with the ability to train, mentor, and developquality 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 thempractically.? Computing skills (Word, Excel, PowerPoint) to generate reports and maintainrecords.Equal Opportunity Employer Statement: GummyWorks is an equal opportunity employer.We celebrate diversity and are committed to creating an inclusive environment for allemployees.

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