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 the establishment of an effective quality system, ensuring its healthy operation in all GMP functions/processes during daily operations.
3. Ensure procedures and other instructions/documents are reviewed and approved appropriately.
4. Ensure starting materials, packaging materials, etc., are sourced from approved suppliers and released per established procedures.
5. Provide sufficient quality oversight on the shop floor, ensuring manufacturing and testing activities are carried out according to established procedures.
6. Ensure premises, utilities, and equipment are qualified and that 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. Ensure that each batch of medicinal products has been manufactured and checked in compliance with the regulations and internal procedures.
10. Ensure all necessary testing is carried out and the associated records evaluated.
11. Ensure appropriate process/method qualification and/or validations are carried out per internal procedure.
12. Ensure all quality events, e.g., deviations, change control, OOS, complaints, etc., are thoroughly investigated and/or assessed, with all necessary actions in place.
13. Participate in regular management reviews of process performance, product quality, and the Pharmaceutical Quality System, advocating for continual improvement.
14. Ensure the stability program is completed per internal procedure.
15. Ensure 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. Participate in product recalls or mock recalls when they occur.
19. Maintain a good relationship with clients' QA.
20. Team management.

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. 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 startups is preferred.
8. Preferably have ADC manufacturing and quality management experience.
9. Familiarity with quality management requirements throughout the whole product lifecycle, including process development, clinical, and commercialization.