Job Description - Manufacturing QAJob SummaryResponsible for overseeing manufacturing and testing activities, ensuring compliance with internal procedures and regulatory requirements. Responsibilities Oversee on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures.Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.Provide quality oversight for validation and re-qualification activities, ensuring validation status is consistently maintained.Review and approve manufacturing and testing-related documents.Authorize the release of facilities, utilities, equipment, and instruments for production use.Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.Support both internal and external audits.Responsible for batch documentation review.Carry out additional tasks as assigned by leadership.QualificationsBachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.8-10 years of experience in production and/or quality management (QA/QC), with a minimum of 8 years in production QA.Familiar with FDA, EMEA, and PICS GMP requirements.Knowledgeable in biological product manufacturing and related quality control requirements.Experience in biopharma commercial supply is preferred.Experience with a new site start-up is preferred.ADC manufacturing and quality management experience is a plus.Proficient in English listening, speaking, reading, and writing.Skilled in Microsoft Word, Excel, PowerPoint, etc.Strong learning ability.Excellent cross-functional communication and collaboration skills.Strong logical thinking and conflict management abilities.Demonstrates strong ownership.