Operation QA Lead

Job Responsibilities:

1. Responsible for routine quality oversight on site GMP production and testing, ensuring all GMP activities are executed following company procedures.
2. Support to establish an effective quality system, ensuring its healthy running in all GMP functions/processes during daily operations.
3. Ensuring procedures and other instructions/documents are reviewed and approved appropriately.
4. Ensuring starting materials, packaging materials, etc. are sourced from approved suppliers and released per established procedures.
5. Ensuring sufficient quality oversight on the shop floor, ensuring manufacturing and testing activities are carried out according to established procedures.
6. Ensuring premises, utilities, and equipment are qualified, and an appropriate maintenance program is in place to maintain the qualification status.
7. Approve product specifications and batch disposition of drug substance and drug product.
8. Ensuring all necessary testing is carried out and the associated records evaluated.
9. Ensuring the appropriate process/method qualification and/or validations are carried out per internal procedure.
10. Ensuring all quality events, e.g., deviation, change control, OOS, complaint, etc. are thoroughly investigated and/or assessed, with all necessary actions in place.
11. Participation in regular management reviews of process performance, product quality, and the Pharmaceutical Quality System, advocating continual improvement.
12. Ensuring the stability program is completed per internal procedure.
13. Ensuring the completion of product quality review per internal procedure.
14. Ensure starting materials, packaging materials, intermediates, and products are stored under appropriate storage conditions.

Requirements:

1. Bachelor's degree or above, majoring in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant majors.
2. Minimum 15+ years of working experience in production and/or quality management (QA/QC), with a minimum of 8+ years in manufacturing QA.
3. 5-8 years of experience in team management.
4. Familiarity with FDA, EMEA, PICS GMP requirements.
5. Familiarity with biological product manufacturing and quality control-related requirements.
6. Experience with Biopharma commercial supply is preferred.
7. Experience with new site startup is preferred.
8. Prefer to have ADC manufacturing and quality management experience.
9. Familiarity with quality management requirements throughout the whole product lifecycle, including process development, clinical, and commercialization.