Product Quality Assurance Supervisor

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. 

• Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, eQMS and LIMS systems 

• Experience with visual inspection, AQL programs, deviations, CAPAs, and manufacturing support activities. 

• Strong communication, leadership, and organizational skills. 

QUALIFICATIONS

Master’s Degree and 2+ years’ experience in Quality Assurance or a DEA related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR Bachelor’s Degree and 3+ years’ experience in Quality Assurance or a DEA related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.