Job Summary
Responsible for overseeing timely and compliant disposition of GMP materials and products, ensuring adherence of critical quality attributes to applicable internal procedures and regulatory requirements.
Responsibilities
- Review and approve GMP manufacturing batch records and related quality documentations.
- Responsible for ensuring all material qualification activities are completed and documented prior to use in GMP manufacturing
- Approve or reject batches based on established specifications, SOPs and regulatory requirements.
- Collaborate with Procurement, QC, Warehouse and Manufacturing to maintain qualified supplier and material status.
- Collaborate with QA and manufacturing teams to resolve discrepancies, deviations, and CAPAs prior to disposition.
- Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
- Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
- Support both internal and external audits.
- Carry out additional tasks as assigned by leadership.
Qualifications
- Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
- 5-10 years of relevant QA experience (preferably in Lot Disposition) in Biopharma or Pharmaceuticals industry
- Familiar with FDA, EMEA, and PICS GMP requirements.
- Knowledgeable in biological product manufacturing and related quality control requirements.
- 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.
