Responsibilities

- Manage packaging jobs in China TPMs in partnership with support functions including CDSM and global PDQA, ensuring requests are completed within required timeline and in compliant with GMP & AbbVie procedures.

- Drive continuous process optimization of local packaging by collaborating with external vendors and internal stakeholders (e.g., CDSM, PDQA) to improve efficiency and shorten turnaround timeline.

- Manage and improve China site shipment by working with cross-functional teams, including CDSM, CSM, and Regulatory, to reduce product waste and ensure efficient & smooth site delivery.

- Establish and maintain China site shipment requirements database by working with CSM and third-party vendors. Leverage data insights to identify trends, risks, and opportunities for operational improvement.

- Support China IP supply kickoff meeting process by coordinating with cross-functional teams (e.g., CDSM, China / global clinical operation teams), ensuring timely alignment and IP readiness for study start-up.

- Support China Health Authority inspection for clinical supply related queries.

- Support local clinical supply Standard Operating Procedures (SOPs) or Work Instructions (WI) creation in partnership with CDSM, Regulatory, QMTC and QA.

- Ensure adherence to local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in conducting clinical trial supply. Stay updated on new and evolving local regulations, guidelines, and policies.

- Establish and maintain relationships with global and local cross-functional teams, clinical sites, and dispensing & destruction depots to ensure reliable delivery/destruction of the IP.

- Perform other duties as assigned by line manager.