Site Quality Compliance Sr. Manager/Associate Director 治疗中心资质认证高级经理/副总监
主要职责:

1. Leading to construct the site quality management system to guarantee apheresis collectingprocess\drug product thawing and infusion process complied with the GMP requirement.

2. Leading to finish commercial product site qualification to guarantee qualified ATC(apheresis and therapeutic center).

3. Leading to finish deviation investigation of site quality scope.

4. Leading to finish change control assessment and report to regulator if necessary.

5. Leading to write commercial product annual quality review report. related to ATC.

6. Work with Commercial team to guarantee the operation on ATC under control.

7. Provide training and guidance on GMP regulation for Commercial team member.


任职要求:

1. Bachelor degree or above in medicine/pharmacology, biology, or comparable relevant experience.

2. At least 10 years QA management experience including at least 5 years Biopharma GSP/GMP experience; quality system setup experience is preferred.

3. Good interpersonal and communication (written and oral) skills.

4. Understanding of regulatory requirements.

5. Good English skills (oral and written).

6. Good team work and problem solving abilities.


招聘人数:1
联系方式:
human_resources@fosunkitebio.com