Clinical Supply Manager

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.

Qualifications :

Qualifications:

- Bachelors Degree or above with at least 8 years of experience in pharmaceutical R&D industry including at least 5 years in clinical supply chain CMC or clinical operation related roles.

- High degree of flexibility and a strong aptitude for identifying innovative approaches in decision-making and problem-solving. Must proactively and effectively recognize quantify and mitigate potential risks.

- Proven leadership skills in managing complex projects.

- Ability to think in multiple dimensions and balance priorities to ensure timely and budget-friendly supply delivery of the highest quality while adhering to regulatory requirements.

- Ability to work independently with a strong team-oriented mindset and collaborative spirit.

- Strong ownership proactive mindset and effective execution capability.

- Strong presentation and communication skills with the ability to clearly articulate ideas and effectively engage with cross-functional stakeholders.

- Knowledge of GMP GCP GTC etc. on clinical supply operations in China.

- Experience working with contract pharmaceutical organizations in China.

- Fluent in spoken and written Chinese and English.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time