Manufacturing QA Senior Specialist (Drug Product)

Job Summary

Responsible 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.

Qualifications

. Bachelor'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.