Operation QA Lead

Job Role

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 operation.
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.
8. Batch disposition of drug substance and drug product.
9. Ensuring that each batch of medicinal products has been manufactured and checked in compliance with the regulations and internal procedures.
10. Ensuring all necessary testing is carried out and the associated records evaluated.
11. Ensuring the appropriate process/method qualification and/or validations are carried out per internal procedure.
12. Ensuring all quality events, e.g., deviation, change control, OOS, complaint, etc., are thoroughly investigated and/or assessed, with all necessary actions in place.
13. Participation in regular management reviews of process performance, product quality, and of the Pharmaceutical Quality System, advocating continual improvement.
14. Ensuring the stability program is completed per internal procedure.
15. Ensuring the completion of product quality review per internal procedure.
16. Ensure starting materials, packaging materials, intermediates, and products are stored under appropriate storage conditions.
17. Support internal and external audits.
18. Participation in product recall or mock recall when it occurs.
19. Maintaining a good relationship with clients' QA.
20. Team management.
21. Other tasks assigned by the supervisor.

Requirements

1. Bachelor's degree or above, majoring in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant majors.
2. 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. Familiar with FDA, EMEA, PICS GMP requirements.
5. Familiar with Biological product manufacturing and quality control related requirements.
6. Experience with Biopharma commercial supply is preferred.
7. Experience with new site start-up is preferred.
8. Preferred to have ADC manufacturing and quality management experience.
9. Familiar with quality management requirements throughout the whole product lifecycle, including process development, clinical, and commercialization.