QA Manager - 172434

Responsibilities: of the Quality Assurance Manager include: Manage daily operations and performance of the Quality Assurance and Document Control staff. Review, approve, and maintain quality documentation including deviations, CAPAs, change controls, investigations, procedures, protocols, and qualification records. Lead regulatory inspections, internal audits, supplier audits, and support audit readiness activities. Oversee document control processes, eDMS administration, training workflows, employee training records, and controlled document management. Manage product complaints, supplier complaints, adverse events, and risk assessments through investigation and closure. Perform QA oversight of manufacturing activities including room release, batch record review, critical process observation, and issue resolution. Ensure compliance with cGMP requirements, FDA regulations, company SOPs, and quality systems. Develop quality metrics/KPIs, support process improvements, and coordinate cross-functional quality initiatives. Review Quality Control testing data and support raw material and consumable release activities. Provide quality and eDMS training to internal and external users. Qualifications: for the Quality Assurance Manager include: Bachelor's degree in a scientific discipline or equivalent experience; Associate degree considered with additional relevant experience. 8+ years of experience in a GMP-regulated environment within the pharmaceutical, biotechnology, or related industry. Experience working in an FDA-regulated environment with direct involvement in regulatory inspections. Strong knowledge of cGMP requirements and US/EU regulatory standards. Previous leadership or supervisory experience managing QA personnel preferred. Experience with document control systems, preferably MasterControl. Strong technical writing, organization, communication, and problem-solving skills. Compensation: for Quality Assurance Manager includes: Rate Range: $115,000 - $135,000 annually Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law This job is open for applications on August 19th, 2026. Applications will be accepted at least 30 days from the posting date.