Product Quality Assurance Supervisor

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! The Product Quality Assurance Supervisor is responsible for the daily leadership and execution of the Acceptable Quality Level (AQL) and Quality on the Floor (QAOTF) programs. This position provides direct supervision of QA Specialists supporting manufacturing operations, ensuring continuous quality oversight of production activities, visual inspection programs, and real-time GMP compliance. The Supervisor serves as the primary Quality representative supporting manufacturing operations across all production shifts while driving consistent execution of QAOTF activities. ### ESSENTIAL DUTIES & RESPONSIBILITIES - Directly supervise the AQL and Quality on the Floor teams. - Provide coaching, mentoring, performance management, and employee development. - Manage staffing, scheduling, workload balancing, and shift coverage to support manufacturing operations, including evenings and weekends. - Conduct performance evaluations and establish development plans. - Ensure effective QA presence during manufacturing operations. - Provide real-time GMP oversight of production activities. - Ensure manufacturing follows approved batch records, SOPs, and GMP requirements. - Escalate quality concerns to QA Management as appropriate. - Manage the Quality Assurance AQL and visual inspection program. - Ensure inspection activities are performed in accordance with approved procedures. - Maintain AQL visual inspection qualification programs. - Partner with Manufacturing to establish inspection standards and qualification requirements. - Monitor inspection trends and recommend process improvements. - Partner with Manufacturing leadership to coordinate QAOTF support. - Ensure appropriate QA coverage for production schedules. - Support and review investigations, deviations, CAPAs, and change controls impacting manufacturing operations. - Support batch record review and batch disposition/release activities. - Participate in production meetings and provide Quality input. - Ensure compliance with FDA, EMA, ICH, and company procedures. - Identify compliance risks and implement corrective actions. - Assist with internal audits, client audits, and regulatory inspections. - Track and report department metrics including inspection effectiveness, QA observations, and compliance trends. - Recommend improvements to QAOTF processes and inspection programs. - Communicate quality issues promptly to the Product QA Manager. - Build collaborative relationships across Manufacturing, QC, Validation, Engineering, and Supply Chain. - Promote a quality-focused culture throughout manufacturing operations. ### KNOWLEDGE, SKILLS, & ABILITIES - GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.